medical Class II Updated 2022-04-13

Abbott Molecular, Inc. recalls Alinity m HBV AMP Kit (US and CE)

Recalled Product

Alinity m HBV AMP Kit (US and CE)


Hazard / Issue

There is a potential for misquantitation high results for negative samples.

Issued by

FDA

Affected States: AZ, CA, IL, IN, MA, MI, MO, NH, NJ, NY, OH, SD, TX, VA
Lot/Code Info: List Numbers: 1) 08N47-095 (US); Lots: 519756, 523799, and 524361, Updated to add: 381583, 529391, 529687, 530273, 531598; 2) 08N47-090 (CE); Lots: 519755, 520957, 522137, 523798, and 524059, Updated to add: 380963, 380979, 381021, 529378, 529686, 530272, 531189, 531596
View official government recall

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