medical Class I Updated 2021-10-20

Abbott Molecular, Inc. recalls Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SA

Recalled Product

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


Hazard / Issue

There is a potential for false positive results.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: 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
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