medical Class I Updated 2021-10-20

Abbott Molecular, Inc. recalls Alinity m Resp-4-Plex AMP Kit (Non-US Assay) and Alinity m R

Recalled Product

Alinity m Resp-4-Plex AMP Kit (Non-US Assay) and Alinity m Resp-4-Plex 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: 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
View official government recall

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