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U.S. Department of Health and Human Services

Class 1 Device Recall Alinity m SARSCoV2 Amp Kit Assay

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  Class 1 Device Recall Alinity m SARSCoV2 Amp Kit Assay see related information
Date Initiated by Firm September 02, 2021
Create Date October 14, 2021
Recall Status1 Open3, Classified
Recall Number Z-0004-2022
Recall Event ID 88626
Product Classification Reagents, 2019-novel coronavirus nucleic acid - Product Code QJR
Product Alinity m SARS-CoV-2 Amp Kit (Emergency Use Authorization, US Assay)
Code Information List Number: 09N78-095; Lot/Serial and Expiration: 511810 9/18/2021 512026 9/21/2021 512900 10/14/2021 513146 10/14/2021 513583 11/18/2021 513959 11/23/2021 514176 11/23/2021 514216 12/1/2021 514819 12/17/2021 515052 1/5/2022 515653 1/28/2022 515949 2/5/2022 516085 2/11/2022 516611 2/22/2022 517139 3/1/2022 517355 3/8/2022 517999 3/19/2022 518266 3/22/2022 518435 3/22/2022 518670 4/1/2022 519124 5/3/2022 519583 5/11/2022 519785 5/18/2022 519968 5/25/2022 520216 6/8/2022 520699 6/30/2022 521106 7/13/2022 521654 7/23/2022 521842 7/27/2022 521857 7/27/2022 
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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