| Event ID |
63467 |
|---|
| Product Type |
Devices |
|---|
| Status |
Ongoing |
|---|
| Recalling Firm |
Biomerieux Inc |
|---|
| City |
Hazelwood |
|---|
| State |
MO |
|---|
| Country |
US |
|---|
| Voluntary/Mandated |
Voluntary: Firm Initiated |
|---|
| Recall Initiation Date |
2012-10-16 |
|---|
| Initial Firm Notification of Consignee or Public |
E-Mail |
|---|
| Distribution Pattern |
Worldwide Distribution - USA including AR, AZ, CA, FL, KS, LA, MD, MN, MT, NC, NV, NY, OR, PA, RI, SC, TX, VA and WA. Internationally to Argentina, Armenia, Austria, Bangladesh, Bosnia and Herzegowina, Brazil, Bulgaria, Burkina FASO, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, COTE DIVOIRE, CROATIA, CZECH REPUBLIC, DOMINICAN REPUBLIC, ECUADOR, EGYPT, EL SALVADOR, FRANCE, FRENCH POLYNESIA, GERMANY, GREECE, GUATEMALA, HONDURAS, HONG KONG, INDIA, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KENYA, REPUBLIC OF KOREA, KUWAIT, LATVIA, LITHUANIA, MALTA, MEXICO, NETHERLANDS, NEW CALEDONIA, NEW ZEALAND, PANAMA, PERU, POLAND, PORTUGAL, ROMANIA, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TUNISIA, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, UNITED STATES, URUGUAY, VENEZUELA, VIETNAM, PALESTINE, AND SERBIA. |
|---|
| Product Description |
Code Info |
Classification |
Reason for Recall |
Product Quantity |
Recall Number |
| bioMerieux BacT/ALERT Control Module, catalog number 210147, Clinical instrument
The product is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin. |
Identified by B.40 firmware |
Class II |
The product may mislabel patient information on culture specimen bottles due to a software miscommunication. |
70 modules |
Z-0299-2013 |
| bioMerieux BacT/ALERT Combo Module, catalog number, 200290, Clinical instrument
The product is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin. |
Identified by B.40 firmware |
Class II |
The product may mislabel patient information on culture specimen bottles due to a software miscommunication. |
375 modules |
Z-0300-2013 |
| bioMerieux BacT/ALERT 3D 60, catalog number, 248009, Clinical instrument
The product is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin. |
Identified by B.40 firmware |
Class II |
The product may mislabel patient information on culture specimen bottles due to a software miscommunication. |
145 modules |
Z-0301-2013 |
| bioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML01, Clinical instrument software, English, Spanish, Italian, catalog number 411814
Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin. |
Identified by B.40 firmware |
Class II |
The product may mislabel patient information on culture specimen bottles due to a software miscommunication. |
1336 kits |
Z-0302-2013 |
| bioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML 02, Clinical instrument software, English, Spanish, Italian, catalog number 411815
Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin. |
Identified by B.40 firmware |
Class II |
The product may mislabel patient information on culture specimen bottles due to a software miscommunication. |
860 kits |
Z-0303-2013 |
| bioMerieux Kit, Instrument & Update, 3D B.40 BTA3D-ZH01, Clinical instrument software, Chinese, catalog number 411816
Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin. |
Identified by B.40 firmware |
Class II |
The product may mislabel patient information on culture specimen bottles due to a software miscommunication. |
30 kits |
Z-0304-2013 |
| bioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML03, Clinical instrument software, Danish, Greek, Polish, Portuguese, catalog number 412623
Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin. |
Identified by B.40 firmware |
Class II |
The product may mislabel patient information on culture specimen bottles due to a software miscommunication. |
250 kits |
Z-0305-2013 |
| bioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML04, Clinical instrument software, Czech, Estonian, Hungarian, Romanian, catalog number 412624
Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin. |
Identified by B.40 firmware |
Class II |
The product may mislabel patient information on culture specimen bottles due to a software miscommunication. |
|
Z-0306-2013 |
| bioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML05, Clinical instrument software, Lithuanian, Latvian, Russian, Slovak, catalog number 412625
Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin. |
Identified by B.40 firmware |
Class II |
The product may mislabel patient information on culture specimen bottles due to a software miscommunication. |
163 kits |
Z-0307-2013 |
| bioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML06, Clinical instrument software, Japanese, Korean, Norwegian, Brazilian, Portuguese, Turkish, catalog number 412626
Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin. |
Identified by B.40 firmware |
Class II |
The product may mislabel patient information on culture specimen bottles due to a software miscommunication. |
671 kits |
Z-0308-2013 |
| bioMerieux Kit, Instrument & Update, 3D B.40 USB-ML01, Clinical instrument software, English, Spanish, Italian, catalog number 411818
Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin. |
Identified by B.40 firmware |
Class II |
The product may mislabel patient information on culture specimen bottles due to a software miscommunication. |
620 kits |
Z-0309-2013 |
| bioMerieux Kit, Instrument & Update, 3D B.40 USB-ML02, Clinical instrument software, German, French, Swedish, catalog number 411925
Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin. |
Identified by B.40 firmware |
Class II |
The product may mislabel patient information on culture specimen bottles due to a software miscommunication. |
556 kits |
Z-0310-2013 |
| bioMerieux Kit, USB HDW, BTA3D60-B-B.40, Clinical instrument software, USB update and mounting hardware-English, catalog number 411956
Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin. |
Identified by B.40 firmware |
Class II |
The product may mislabel patient information on culture specimen bottles due to a software miscommunication. |
205 kits |
Z-0311-2013 |
| bioMerieux Kit, USB HDW, BTA3D COMBO-B-B.40, Clinical instrument software, USB update and mounting hardware-English, catalog number 411957
Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin. |
Identified by B.40 firmware |
Class II |
The product may mislabel patient information on culture specimen bottles due to a software miscommunication. |
205 kits |
Z-0312-2013 |
| bioMerieux Kit, USB HDW, BTA3D CONTROL-B-B.40, Clinical instrument software, USB update and mounting hardware-English, catalog number 411958
Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin. |
Identified by B.40 firmware |
Class II |
The product may mislabel patient information on culture specimen bottles due to a software miscommunication. |
250 kits |
Z-0313-2013 |
| bioMerieux Kit, USB Instrument & Update, 3D B.40 USB-ML03, Clinical instrument software, Danish, Greek, Polish, Portuguese, catalog number 412559
Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin. |
Identified by B.40 firmware |
Class II |
The product may mislabel patient information on culture specimen bottles due to a software miscommunication. |
29 kits |
Z-0314-2013 |
| bioMerieux Kit, Instrument & Update, 3D B.40 USB-ML04, Clinical instrument software, Czech, Estonian, Hungarian, Romanian, catalog number 412620
Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin. |
Identified by B.40 firmware |
Class II |
The product may mislabel patient information on culture specimen bottles due to a software miscommunication. |
28 kits |
Z-0315-2013 |
| bioMerieux Kit, Instrument & Update, 3D B.40 USB-ML05, Clinical instrument software, Lithuanian, Latvian, Russian, Slovak, catalog number 412621
Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin. |
Identified by B.40 firmware |
Class II |
The product may mislabel patient information on culture specimen bottles due to a software miscommunication. |
12 kits |
Z-0316-2013 |
| bioMerieux Kit, Instrument & Update, 3D B.40 USB-ML06, Clinical instrument software, Japanese, Korean, Norwegian, Brazilian, Portuguese, Turkish, catalog number 412622
Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin. |
Identified by B.40 firmware |
Class II |
The product may mislabel patient information on culture specimen bottles due to a software miscommunication. |
69 kits |
Z-0317-2013 |
| bioMerieux BacT/ALERT Control Module, catalog number 210148, Industrial instrument
The product is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin. |
Identified by B.40 firmware |
Class II |
The product may mislabel patient information on culture specimen bottles due to a software miscommunication. |
2 modules |
Z-0318-2013 |
| bioMerieux BacT/ALERT Combo Module, catalog number 200291, Industrial instrument
The product is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin. |
Identified by B.40 firmware |
Class II |
The product may mislabel patient information on culture specimen bottles due to a software miscommunication. |
26 Modules |
Z-0319-2013 |
| bioMerieux BacT/ALERT Combo Module, catalog number 247014, Industrial instrument
The product is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin. |
Identified by B.40 firmware |
Class II |
The product may mislabel patient information on culture specimen bottles due to a software miscommunication. |
2 modules |
Z-0320-2013 |
| bioMerieux Kit, Instrument & Update, 3D IND ZIP-ML 01, Industry instrument software update, English, Spanish, Italian, catalog number 412005
Software update for an instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin. |
Identified by B.40 firmware |
Class II |
The product may mislabel patient information on culture specimen bottles due to a software miscommunication. |
288 kits |
Z-0321-2013 |
| bioMerieux Kit, Instrument & Update, 3D IND USB-ML 02, Industry instrument software update, English, Spanish, Italian, catalog number 412006
Software update for an instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin. |
Identified by B.40 firmware |
Class II |
The product may mislabel patient information on culture specimen bottles due to a software miscommunication. |
20 kits |
Z-0322-2013 |
| bioMerieux Kit, Instrument & Update, B.40 Dualt-ML, Industry instrument software update, English, Spanish, Italian, German, French, Japanese, Brazilian, Portuguese, catalog number 412950
Software update for an instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin. |
Identified by B.40 firmware |
Class II |
The product may mislabel patient information on culture specimen bottles due to a software miscommunication. |
12 kits |
Z-0323-2013 |
| bioMerieux Kit, Instrument & Update, B.40, 3D IND USB-ML01, Industry instrument software update, English, Spanish, Italian, catalog number 412002
Software update for an instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin. |
Identified by B.40 firmware |
Class II |
The product may mislabel patient information on culture specimen bottles due to a software miscommunication. |
83 kits |
Z-0324-2013 |
| bioMerieux Kit, Instrument & Update, B.40, 3D IND USB-ML02, Industry instrument software update, German, French, catalog number 412003
Software update for an instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin. |
Identified by B.40 firmware |
Class II |
The product may mislabel patient information on culture specimen bottles due to a software miscommunication. |
22 kits |
Z-0325-2013 |
| bioMerieux Kit, Instrument & Update, B.40, 3D I USB-ML01, Industry instrument software update, English, Spanish, Italian, catalog number 413481
Software update for an instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin. |
Identified by B.40 firmware |
Class II |
The product may mislabel patient information on culture specimen bottles due to a software miscommunication. |
23 kits |
Z-0326-2013 |
| bioMerieux Kit, Instrument & Update, B.40, 3D I USB-ML02, Industry instrument software update, German, French, catalog number 413482
Software update for an instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin. |
Identified by B.40 firmware |
Class II |
The product may mislabel patient information on culture specimen bottles due to a software miscommunication. |
10 kits |
Z-0327-2013 |
| bioMerieux Kit, Instrument & Update, B.40, 3D I ZIP-ML01, Industry instrument software update, English, Spanish, Italian, catalog number 413483
Software update for an instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin. |
Identified by B.40 firmware |
Class II |
The product may mislabel patient information on culture specimen bottles due to a software miscommunication. |
33 kits |
Z-0328-2013 |
| bioMerieux Kit, Instrument & Update, B.40, 3D I ZIP-ML02, Industry instrument software update, English, Spanish, Italian, catalog number 413484
Software update for an instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin. |
Identified by B.40 firmware |
Class II |
The product may mislabel patient information on culture specimen bottles due to a software miscommunication. |
5 kits |
Z-0329-2013 |
