medical Class II Updated 2022-04-13

Abbott Molecular, Inc. recalls Alinity m HBV Application Specification File (US and CE)

Recalled Product

Alinity m HBV Application Specification File (US and CE)


Hazard / Issue

There is a potential for misquantitation high results of 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) 08N47-03A (US); Version 1.00 2) 08N47-01B (CE); Version 2.00 3) 08N47-01C (CE); Version 3.00
View official government recall

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