FILMARRAY 2 recalled over Salmonella risk

Recall date

August 7, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

BioFire Diagnostics, LLC recalls FILMARRAY 2.0 INSTRUMENT, REF: FLM2-ASY-0001, FLM2-ASY-0001-W

Recall number

Z-3122-2024

FDA classification

Class II

Brand / firm

BioFire Diagnostics, LLC

Sold / distributed

Worldwide - US Nationwide distribution including in the states of NC, TX, OH, CA, KS, AL, WA, NY, PA, IL, WI, KY, LA, NE, FL, UT, IA, SC, VA, AZ, CO, WV, MO, TN, MN, DC, DE, OK, WY, IN, NJ, NM, ID, OR, MS, SD, MI, MT, GA, HI, NV, MD, MA, AR, NH, PR, ND, VT, CT, AK, ME, RI and the countries of Korea…

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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