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U.S. Department of Health and Human Services

Class 2 Device Recall Abbott Alinity m

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  Class 2 Device Recall Abbott Alinity m see related information
Date Initiated by Firm August 19, 2022
Create Date September 06, 2022
Recall Status1 Open3, Classified
Recall Number Z-1679-2022
Recall Event ID 90789
Product Classification Reagents, 2019-novel coronavirus nucleic acid - Product Code QJR
Product Abbott Alinity m SARS-CoV-2 CTRL Kit, REF 09N78-085, each kit contains 12 x 1.3mL CTRL - and 12 x 1.3 mL CTRL +, For In Vitro Diagnostic Use.
Code Information Lot #530738, UDI (01)00884999049208(10)530738(17)230527(240)09N78-085.
Recalling Firm/
Manufacturer		 Abbott Molecular, Inc.
1300 E Touhy Ave
Des Plaines IL 60018-3315
For Additional Information Contact Ray Bastian
224-361-7000
Manufacturer Reason
for Recall		 Reports received of an increase of message code 9186 (internal control failed) when using the kit.
FDA Determined
Cause 2		 Under Investigation by firm
Action The firm issued recall letters dated 8/19/2022 via FedEx priority overnight express on 8/19/2022. The letters provided the background, potential impact, and necessary actions. The necessary actions included contacting Abbott Customer Support for replacement of any unused kits in the consignee's inventory of the affected lot number and discard any inventory in their possession. If replacement inventory is not available, the consignee was told they may continue to use the affected product until replacement material is obtained. They are to ensure that valid Control values are obtained for all control levels prior to reporting results as specified in the associated package Insert. A Customer Reply Form was enclosed for completion and return. If the consignee has forwarded any kits of the affected lot to other laboratories, they are instructed to inform them of the recall, provide them a copy of the letter, and have them take the necessary actions listed. The letter also instructs the consignee to inform their laboratory personnel of the issue and retain a copy of the communication for further reference.
Quantity in Commerce 579 kits
Distribution Distribution was made to AZ, CA, CT, FL, GA, IL, KS, KY, LA, MA, MI, MN, MO, NC, NJ, NV, NY, OK, PA, RI, TN, TX, WA, and WI. There was government distribution but no military distribution. Foreign distribution was made to Chile and Taiwan.
Total Product Life Cycle TPLC Device Report
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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