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U.S. Department of Health and Human Services

Class 1 Device Recall Alinity m Resp4Plex AMP Kit (NonUS Assay)

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  Class 1 Device Recall Alinity m Resp4Plex 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-0008-2022
Recall Event ID 88626
Product Classification Reagents, 2019-novel coronavirus nucleic acid - Product Code QJR
Product Alinity m Resp-4-Plex AMP Kit (Non-US Assay)
Code Information List Number: 09N79-090; Lot/Serial and Expiration:  513424 10/13/2021 513771 10/13/2021 513861 11/6/2021 514503 11/19/2021 515652 12/2/2021 516411 11/6/2021 517877 12/2/2021 518436 12/10/2021 518877 12/10/2021 519091 11/6/2021 519582 5/10/2022 519969 5/10/2022 520356 5/10/2022 520695 7/8/2022 
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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