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U.S. Department of Health and Human Services

Class 1 Device Recall Alinity m Resp4Plex AMP Kit Assay

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  Class 1 Device Recall Alinity m Resp4Plex AMP Kit Assay see related information
Date Initiated by Firm September 02, 2021
Date Posted October 14, 2021
Recall Status1 Open3, Classified
Recall Number Z-0005-2022
Recall Event ID 88626
Product Classification Reagents, 2019-novel coronavirus nucleic acid - Product Code QJR
Product Alinity m Resp-4-Plex AMP Kit (Emergency Use Authorization, US Assay) and Alinity m Resp-4-Plex Application Specification File. in vitro diagnostic
Code Information List Number: 09N79-096, UDI 00884999049390; Lot/Serial, Expiration: 514074, 09/15/2021; 519243, 05/10/2022; 519243, 5/10/2022; 522088, 8/4/2022; 522128, 8/26/2022; 523152, 10/10/2022; 524433, 1/15/2023; 526710, 1/21/2023; 527845, 2/8/2023; List Number 09N79-05D, UDI (01) 00884999050242(240 )09N79-05D(8012)4.oo
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 firm issued an Urgent Field Safety Notice/Field Correction Recall 09/02/2021 to all impacted customers. Per the customer letter, all positives are to be considered presumptive 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 the customer site. On 03/30/2022, Abbott Molecular issued a follow-up Urgent Field Safety Notice/Field Correction Recall letter to all customers who ordered Alinity m SARS-CoV-2 AMP Kit Emergency Use Authorization (EUA), List Number 09N78-095 and/or Alinity m Resp-4-Plex AMP Kit EUA, List Number 09N79-096 used with the Alinity m System. Also to customers who ordered Alinity m SARS-CoV-2 AMP Kit (CE), List Number 09N78-090 or 09N78-091 and/or Alinity m Resp-4-Plex AMP Kit (CE), List Number 09N79-090 used with the Alinity m System. The Customer Letter explains Abbott has updated the existing Application Specification files for Alinity m SARS-CoV-2 and Resp-4-Plex to further reduce the potential for carryover. FDA has not yet authorized the Alinity m SARS-CoV-2 Application Specification file version 6 update or the Alinity m Resp-4-Plex Application Specification file version 5 update. Implementation of the modification for Alinity m SARS-CoV-2 and Resp-4-Plex will occur when the update to the Application Specification file has been authorized. A Molecular Diagnostics Abbott Representative will be contacting you once the updated Application Specification files are available. If you have any questions, please contact your local Molecular Diagnostics Abbott representative or call Abbott Technical Support at 1-800-553-7042 Option 2.
Quantity in Commerce 8469 units
Distribution Worldwide Distribution. US Nationwide, 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, and 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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