| Class 3 Device Recall Architect BNP Controls | |
Date Initiated by Firm | May 24, 2019 |
Create Date | July 25, 2019 |
Recall Status1 |
Terminated 3 on April 01, 2021 |
Recall Number | Z-2079-2019 |
Recall Event ID |
83053 |
510(K)Number | K060964 |
Product Classification |
Single (specified) analyte controls (assayed and unassayed) - Product Code JJX
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Product | ARCHITECT BNP Controls
Ptoduct Usage:
The ARCHITECT BNP Controls are for the estimation of test precision and the detection of
systematic analytical deviations of the ARCHITECT iSystem (reagents, calibrators and instrument), when used for the quantitative determination of human B type natriuretic peptide (BNP) in human EDTA plasma. |
Code Information |
a. List Number 8K28 11 - Lot Number (Expiration Date) UDI: 44K78918 (18JUN2019) (01)00380740017477(17)190618(10)44K78918, 44K80918 (05SEP2019) (01)00380740017477(17)190905(10)44K80918, 44K82718 (15NOV2019) (01)00380740017477(17)191115(10)44K82718; b. List Number 8K28 12 - Lot Number (Expiration Date) UDI: 44K79518 (23Jul2019) (01)00380740145262(17)190723(10)44K79518, 44K81118 (5Sep2019) (01)00380740145262(17)190905(10)44K81118, 44K82818 (15Nov2019) (01)00380740145262(17)191115(10)44K82818, 44K84219 (17Dec2019) (01)00380740145262(17)191217(10)44K84219 |
Recalling Firm/ Manufacturer |
Abbott Laboratories 100 Abbott Park Rd Bldg Ap8b Abbott Park IL 60064-3502
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For Additional Information Contact | Albert Chianello 224-668-1923 |
Manufacturer Reason for Recall | Presence of a time dependent, stability drift in patient and control results returned from ARCHITECT BNP testing. |
FDA Determined Cause 2 | Under Investigation by firm |
Action | Abbott Laboratories notified customers on about 05/24/2019 via "Product Recall" letter. If customers did not have an alternate calibrator and/or control lots available in inventory and a valid calibration calibration curve has been generated, then customers should immediately order replacement calibrator
and/or control lots. Valid calibration curves generated with the affected calibrator lots can still be used as long as controls not listed on the customer notification letter remain within range. The control lots listed in the letter CANNOT be used to validate the calibration curves. Destroy any inventory of the affected lots
according to your laboratory procedures.
If customers have alternate calibrator and/or control lots available in inventory, then discontinue use of the impacted lots immediately and switch to the alternate calibrator and/or control lots. Destroy any remaining inventory of the
calibrator and/or control lots according to your laboratory practices.
For customers who have, and are currently using, specified lots (outlined in the customer letter), expiration dates should be adjusted as instructed. Reference customer letter. The ARCHITECT software will continue to track to original dating as assigned during the manufacture of these lots. Manual tracking of the newly assigned expiration dates will have to be performed for each individual instrument, kit, and laboratory. Obtain replacement calibrator and/or controls prior to adjusted expiration to maintain testing.
All future calibrator and control lots will have shortened expiration dating and will
require adjustments to laboratory inventory and order management practices. Please contact your local Abbott representative for assistance and advice on optimization of workflow in your laboratory.
Customers were also instructed to complete and return the Customer Reply form, notify customers if the affected products were further distributed, and retain a copy of the letter for lab |
Quantity in Commerce | 6,623 units |
Distribution | Worldwide Distribution - US Nationwide in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY.
Distributed worldwide to ALGERIA, ANDORRA, AUSTRIA, AZERBAIJAN, BANGLADESH, BELARUS, BELGIUM, BOSNIA AND HERZEGOVI, BRUNEI, BULGARIA, CANADA, CAYMAN ISLANDS, CHILE, CROATIA, CURACAO, CYPRUS, CZECH REPUBLIC, DENMARK, ECUADOR, EL SALVADOR, ESTONIA, FINLAND, FRANCE, GAZA & JERICHO, GEORGIA, GERMANY, GREECE, GREENLAND, HONDURAS, HUNGARY, IRAN, IRAQ, IRELAND, ISRAEL, ITALY, JORDAN, KAZAKHSTAN, KUWAIT, KYRGYZSTAN, LEBANON, LITHUANIA, LUXEMBOURG, MACEDONIA, MALDIVES, MALI, MAURITANIA, MONTENEGRO, MOROCCO, NETHERLANDS, NORWAY, OMAN, PAKISTAN, PANAMA, PARAGUAY, POLAND, PORTUGAL, ROMANIA, SAUDI ARABIA, SENEGAL, SERBIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SPAIN, SRI LANKA, SWITZERLAND, TANZANIA, TRINIDAD & TOBAGO, TUNISIA, TURKEY, UAE, UGANDA, UNITED KINGDOM, VIETNAM, ZIMBABWE. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = JJX
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