medical Class I Updated 2021-10-20

Abbott Molecular, Inc. recalls Alinity m Resp-4-Plex AMP Kit (Emergency Use Authorization,

Recalled Product

Alinity m Resp-4-Plex AMP Kit (Emergency Use Authorization, 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: 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
View official government recall

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