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Alinity m recallZ-0007-2022 · Abbott Molecular, Inc. · initiated Sep 2, 2021

Terminated

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Abbott Molecular, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

There is a potential for false positive results.

FDA root cause category: Device Design

What the company is doing

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.

Recall details

Recall number
Z-0007-2022
Status
Terminated
Initiated by the company
Sep 2, 2021
Posted by the FDA
Oct 14, 2021
Recalling firm
Abbott Molecular, Inc.
Quantity
11408 units
Product code
QJR
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.

Product description

Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic

Code information (models, lots, serial numbers)

List Number: 09N78-091, UDI 00884999049222; Lot/Serial, Expiration: 520596, 06/18/2022; 520952, 07/09/2022; 524054, 10/18/2022; 524965, 10/25/2022; 525462, 12/10/2022; 525768, 12/16/2022; 526708, 01/18/2023; 527842, 02/08/2023; List Number 09N78-03E, UDI (01)00884999050211(240)09N78-03E(8012)5.oo

Devices named in this recall

2 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other products in the same recall event

The FDA groups related products into one recall event (event 88626).

Sources and updates

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