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U.S. Department of Health and Human Services

Class 1 Device Recall Alinity m SARSCoV2 Amp Kit (NonUS Assay)

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  Class 1 Device Recall Alinity m SARSCoV2 Amp Kit (NonUS Assay) see related information
Date Initiated by Firm September 02, 2021
Create Date October 14, 2021
Recall Status1 Open3, Classified
Recall Number Z-0006-2022
Recall Event ID 88626
Product Classification Reagents, 2019-novel coronavirus nucleic acid - Product Code QJR
Product Alinity m SARS-CoV-2 Amp Kit (Non-US Assay)
Code Information List Number: 09N78-090; Lot/Serial and Expiration:  511468 9/15/2021 511504 9/15/2021 511505 9/15/2021 512025 9/21/2021 512416 9/18/2021 512417 9/18/2021 512705 9/21/2021 512712 10/7/2021 512898 10/7/2021 513147 10/14/2021 513629 11/18/2021 514359 12/1/2021 514762 12/17/2021 515053 1/5/2022 515415 1/15/2022 515416 1/15/2022 515948 1/28/2022 516084 2/5/2022 516430 2/17/2022 516431 2/18/2022 516612 2/25/2022 516636 3/1/2022 516910 3/4/2022 516911 2/11/2022 517009 2/18/2022 517138 2/25/2022 517354 3/8/2022 517876 3/19/2022 517998 3/19/2022 518668 4/1/2022 518669 4/20/2022 518878 4/20/2022 519022 4/30/2022 519122 4/30/2022 519372 5/3/2022 519373 5/11/2022 519784 5/18/2022 519967 5/25/2022 520221 6/8/2022 520387 6/15/2022 520388 6/15/2022 520563 6/18/2022 
Recalling Firm/
Manufacturer
Abbott Molecular, Inc.
1300 E Touhy Ave
Des Plaines IL 60018-3315
For Additional Information Contact Ray Bastian
224-668-3866
Manufacturer Reason
for Recall
There is a potential for false positive results.
FDA Determined
Cause 2
Material/Component Contamination
Action The recalling firm issued an Urgent Field Safety Notice/Field Correction Recall to all impacted customers. Customers are required to complete and return the receipt acknowledgement. Per the customer letter, all positives are to be considered presumtive until the Alinity m SARS-CoV-2 Application Specification file version 5 or the updated Alinity m Resp-4-Plex Application Specification file is implemented at customer site.
Quantity in Commerce 563 unitsin total
Distribution Distribution throughout the United States Nationwide. OUS Distribution: AUSTRALIA AUSTRIA BELGIUM BRAZIL CANADA COLOMBIA CZECH REPUBLIC ESTONIA FINLAND FRANCE GERMANY HONG KONG IRELAND ISRAEL ITALY JAPAN MALAYSIA MONTENEGRO NETHERLANDS NEW ZEALAND NORWAY POLAND PORTUGAL ROMANIA SAUDI ARABIA SINGAPORE SLOVENIA SOUTH AFRICA SOUTH KOREA SPAIN SWEDEN SWITZERLAND TAIWAN THAILAND UNITED KINGDOM VIETNAM
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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