Reported Sep 18, 2024 · Ongoing
FILMARRAY 2.0 INSTRUMENT, REF: FLM2-ASY-0001, FLM2-ASY-0001-W
BioFire Diagnostics, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: BioFire Diagnostics, LLC · 515 S Colorow Dr · Salt Lake City, UT · 84108-1248
Is this the product you have?
- FILMARRAY 2.0 INSTRUMENT
- REF
FLM2-ASY-0001FLM2-ASY-0001-W
- Lot codes and dates
- FLM2-ASY-0001
- UDI00815381020031
- Serial Numbers
165 of 165 codes
2FA006102FA009512FA009642FA010052FA011152FA011162FA011282FA014182FA016532FA017332FA017712FA017752FA018782FA028052FA029772FA029812FA031942FA031962FA032372FA032732FA033032FA033352FA033432FA060792FA064732FA078842FA079872FA079962FA083862FA012242FAD848B2FA002292FA003862FA003962FA005512FA005582FA016932FA021882FA022962FA023472FA024222FA050862FA050892FA050992FA051722FA051862FA052562FA052732FA052872FA053002FA056012FA060552FA061402FA062362FA062972FA066552FA068672FA070932FA071732FA07175
- UDI00815381029058
- Serial Numbers
836 of 836 codes
2FA000462FA000492FA000502FA000532FA000602FA000662FA000762FA000792FA000902FA000932FA001162FA001172FA001312FA001392FA001422FA001502FA001572FA001592FA001672FA001692FA001722FA001742FA001762FA001852FA001862FA001872FA002092FA002102FA002172FA002202FA002212FA002752FA002782FA002952FA002982FA002992FA003082FA003332FA003402FA003432FA003442FA003462FA003482FA003592FA003602FA003652FA003662FA003692FA003722FA003782FA003902FA004032FA004052FA004132FA004152FA004242FA004352FA004362FA004402FA00442
- Amount recalled
- 1001
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
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.
This product could cause temporary or reversible health problems — stop using it.
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