FDASeptember 10, 2018device
-Outer Kit Box (P/N RFIT-LBL-0140) - FilmArray¿ Meningitis/Encephalitis (ME) Panel REF RFIT-ASY-0118 30 For FilmArray systems LOT KIT UDI (01)00815381020123 CE 0086 IVD -Fitment Label (P/N RFIT-LBL-0138) which identifies the pouch label - FilmArray¿ ME Panel v1.4 LOT SN CE 0086 IVD Product Usage:...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Firm identified an issue in the manufacturing process which might contribute to elevated rates of false positive results for HSV-1 while using the ME Panel. Only specific kits are affected.
What to do
FDA enforcement status: Terminated
Brands named
biofire diagnosticsbiofire
UPCs
00815381020123
Recall history
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