Alinity m recallZ-0004-2022 · Abbott Molecular, Inc. · initiated Sep 2, 2021

Terminated

Is my device affected?

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.
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.
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-0004-2022
Status: Terminated
Initiated by the company: Sep 2, 2021
Posted by the FDA: Oct 14, 2021
Recalling firm: Abbott Molecular, Inc.
Quantity: 60563 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 (Emergency Use Authorization, US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic

Code information (models, lots, serial numbers)

Show the full code information (1k characters)

List Number: 09N78-095, UDI 00884999049222; Lot/Serial, Expiration: 511810, 09/18/2021; 512026, 09/21/2021; 512900, 10/14/2021; 513146, 10/14/2021; 513583, 11/18/2021; 513959, 11/23/2021; 514176, 11/23/2021; 514216, 12/01/2021; 514819, 12/17/2021; 515052, 01/05/2022; 515653, 01/28/2022; 515949, 02/05/2022; 516085, 02/11/2022; 516611, 02/22/2022; 517139, 03/01/2022; 517355, 03/08/2022; 517999, 03/19/2022; 518266, 03/22/2022; 518435, 03/22/2022; 522689, 09/14/2022; 518670, 04/01/2022; 522691, 09/14/2022; 519124, 05/03/2022; 523309, 09/13/2022; 519583, 05/11/2022; 523468, 09/23/2022; 519785, 05/18/2022; 523621, 10/01/2022; 519968, 05/25/2022; 523946, 10/08/2022; 520216, 06/08/2022; 524203, 10/21/2022; 520699, 06/30/2022; 524438, 10/25/2022; 521106, 07/13/2022; 525862, 12/16/2022; 521654, 07/23/2022; 526394, 12/30/2022; 521842, 07/27/2022; 526484, 01/14/2023; 521857, 07/27/2022; 527399, 01/28/2023; 527400, 01/28/2023; 527540, 02/04/2023; 528026, 02/18/2023; List File 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.

Alinity m 09N78-095
Abbott Molecular Inc. · Reagents, 2019-novel coronavirus nucleic acid
3 recalls357 reports
Alinity m 09N78-03E
Abbott Molecular Inc. · Reagents, 2019-novel coronavirus nucleic acid
3 recalls0 reports

Product lines

Alinity mAbbott Molecular Inc. · 13 models · 1,534 reports · 14 recalls

Other products in the same recall event

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

Z-0005-2022 · Terminated
Alinity m Resp-4-Plex AMP Kit (Emergency Use Authorization, US Assay) and Alinity m Resp-4-Plex Application Specification File. in vitro diagnostic
Z-0006-2022 · Terminated
Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic
Z-0007-2022 · Terminated
Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic
Z-0008-2022 · Terminated
Alinity m Resp-4-Plex AMP Kit (Non-US Assay) and Alinity m Resp-4-Plex Application Specification File. in vitro diagnostic

Sources and updates

Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.

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