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FDAAugust 7, 2024device

FILMARRAY 2.0 INSTRUMENT, REF: FLM2-ASY-0001, FLM2-ASY-0001-W

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Some automated in vitro diagnostic modules and instruments manufactured or serviced between May 2022 and May 2024 were calibrated with internal equipment that may lead modules and instruments to report higher melting temperatures, which may lead to erroneous results including false positive Salmonella, Giardia lamblia, false positive/negative Norovirus, and false negative MRSA.

What to do

FDA enforcement status: Ongoing

Brands named

biofire diagnosticsbiofire

UPCs

0081538102003100815381029058

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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