FDA Device recall 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

FDA Device
Class I
terminated
Published 2021-10-20

On 2021-10-20 the FDA classified a Class I recall of Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic by Abbott Molecular, citing there is a potential for false positive results.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-0006-2022
Classification	Class I
Status	terminated
Initiated	2021-09-02
Published	2021-10-20
Last updated	2026-09-13 11:56 UTC
Company	Abbott Molecular
Distribution	US

Product

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

Reason

There is a potential for false positive results.

Identifiers

code_info	List Number: 09N78-090, UDI UDI 00884999049222; Lot/Serial, Expiration: 511468, 09/15/2021; 511504, 09/15/2021; 51… 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; 5

code_info

List Number: 09N78-090, UDI UDI 00884999049222; Lot/Serial, Expiration: 511468, 09/15/2021; 511504, 09/15/2021; 51…

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; 5

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0006-2022%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.