Lower risk Medical device recall · FDA · Published September 2, 2021

Abbott Alinity m SARS-CoV-2 Kit May Give False Positives - Recall

Abbott recalls Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) due to potential false positive results. Affected units have specific lot numbers and expiration dates. Consumers should check their kit details.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0007-2022Medical device Abbott ›

Lower-risk recall

There is a potential for false positive results.

Take action

Contact the company

Recalling firmAbbott Molecular, Inc.1300 E Touhy Ave · Des Plaines, IL 60018-3315

✎ GovInfoNow plain-language explainer

Abbott is recalling its Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) because it may produce false positive results. This could lead to incorrect COVID-19 test outcomes, which might cause unnecessary anxiety or actions. Read more at govinfonow.com/recall/61836-abbott-alinity-m-sars-cov-2-kit-may-give-false.

Source Summary by GovInfoNow · govinfonow.com/recall/61836-abbott-alinity-m-sars-cov-2-kit-may-give-false · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0007-2022

Cite this page

“Abbott Alinity m SARS-CoV-2 Kit May Give False Positives - Recall.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61836-abbott-alinity-m-sars-cov-2-kit-may-give-false. Based on FDA recall #Z-0007-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0007-2022%22&limit=1).

The FDA announced on 2021-09-02 that Abbott Molecular, Inc. is recalling Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Application Specification File due to a potential for false positive results. The agency issued recall number Z-0007-2022 for the in vitro diagnostic devices.

How to tell if you have it

Brand: Abbott
Product: Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Application Specification File
UPC: 00884999050211
Lot/Serial Codes: 520596, 520952, 524054, 524965, 525462, 525768, 526708, 527842
Expiration Dates: 06/18/2022, 07/09/2022, 10/18/2022, 10/25/2022, 12/10/2022, 12/16/2022, 01/18/2023, 02/08/2023
List Numbers: 09N78-091, 09N78-03E
Units Affected: 11408

The hazard

According to the FDA, there is a potential for false positive results with these in vitro diagnostic kits. The recall classification is Class I.

Context

GovInfoNow's records show Abbott Molecular, Inc. has had 19 other recalls since 2021-08-04. Recent similar recalls include the Abbott Alinity m Resp-4-Plex AMP Kit (2025-04-28) and the Abbott Alinity m System (2025-03-20). Other recent recalls of similar products include the Abbott ID NOW Influenza A & B 2 Kit (2026-02-09), the Sperm Ab ELISA Test Kit (2026-07-02), and the Abbott i-STAT Cartridges (2026-04-01).

How to tell if you have this one

Check the kit's lot number and expiration date on the packaging. The affected kits have specific lot numbers listed in the recall notice, such as 520596 (expiration 06/18/2022) and others up to 527842 (expiration 02/08/2023).

Brand
Abbott
Product
Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic
Category
Medical device

FDA recall event · 5 products

All 5 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class I
Status
Terminated
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.

Recall number	Product, codes & lots	Quantity
Z-0004-2022	Alinity m SARS-CoV-2 Amp Kit (Emergency Use Authorization, US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic; 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	60563 units
Z-0005-2022	Alinity m Resp-4-Plex AMP Kit (Emergency Use Authorization, US Assay) and Alinity m Resp-4-Plex Application Specification File. in vitro diagnostic; 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	8469 units
Z-0006-2022	Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic; List Number: 09N78-090, UDI UDI 00884999049222; Lot/Serial, Expiration: 511468, 09/15/2021; 511504, 09/15/2021; 511505, 09/15/2021; 512025, 09/21/2021; 512416, 09/18/2021; 512417, 09/18/2021; 512705, 09/21/2021; 512712, 10/07/2021; 512898, 10/07/2021; 513147, 10/14/2021; 513629, 11/18/2021; 514359, 12/01/2021; 514762, 12/17/2021; 515053, 01/05/2022; 515415, 01/15/2022; 515416, 01/15/2022; 515948, 01/28/2022; 516084, 02/05/2022; 516430, 02/17/2022; 516431, 02/18/2022; 516612, 02/25/2022; 516636, 03/01/2022; 516910, 03/04/2022; 516911, 02/11/2022; 517009, 02/18/2022; 517138, 02/25/2022; 517354, 03/08/2022; 517876, 03/19/2022; 517998, 03/19/2022; 518668, 04/01/2022; 518669, 04/20/2022; 518878, 04/20/2022; 519022, 04/30/2022; 519122, 04/30/2022; 519372, 05/03/2022; 519373, 05/11/2022; 519784, 05/18/2022; 519967, 05/25/2022; 520221, 06/08/2022; 520387, 06/15/2022; 520388, 06/15/2022; 520563, 06/18/2022; 527137, 01/20/2023; 527205, 01/20/2023; 527402, 01/28/2023; 527497, 01/28/2023; 527576, 02/04/2023; 527642, 02/08/2023; 527844, 02/17/2023; 528024, 02/18/2023; List Number: 09N78-03E, UDI (01)00884999050211(240)09N78-03E(8012)5.oo	71314 units
Z-0007-2022	Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic; 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	11408 units
Z-0008-2022	Alinity m Resp-4-Plex AMP Kit (Non-US Assay) and Alinity m Resp-4-Plex Application Specification File. in vitro diagnostic; List Number: 09N79-096, UDI 00884999049390 Lot/Serial, Expiration: 513424, 10/13/2021; 513771, 10/13/2021; 513861, 11/06/2021; 514503, 11/19/2021; 515652, 12/02/2021; 516411, 11/06/2021; 517877, 12/02/2021; 518436, 12/10/2021; 518877, 12/10/2021; 519091, 11/06/2021; 519243, 05/10/2022; 519582, 05/10/2022; 519969, 05/10/2022; 520356, 05/10/2022; 520695, 07/08/2022; 522088, 08/04/2022; 522128, 08/26/2022; 523152, 10/10/2022; 524433, 01/15/2023; 526710, 01/21/2023; 527845, 02/08/2023; List Number 09N79-05D, UDI (01) 00884999050242(240 )09N79-05D(8012)4.oo	5855 units

Based on the official FDA remedy

What to do — step by step

Check Kit Details
Look for the lot number and expiration date on the packaging to determine if your kit is affected.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA 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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA terminated this recall 2.9 years after the firm started it.

Sep 2, 2021Firm started the recall
Oct 14, 2021FDA classified it Class I
Oct 20, 2021Published in FDA’s Enforcement Report
Jul 23, 2024FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Are there any safety risks from using this kit?

The recall is for potential false positives, not physical safety risks. There are no immediate health hazards from using the kit.

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Keep exploring

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Link to this recall

<a href="https://govinfonow.com/recall/61836-abbott-alinity-m-sars-cov-2-kit-may-give-false">Abbott Alinity m SARS-CoV-2 Kit May Give False Positives - Recall (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0007-2022 (September 2, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0007-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.