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U.S. Department of Health and Human Services

Enforcement Report - Week of November 28, 2012

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Event Detail

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 Detail

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
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