medical Class II Updated 2018-11-21

BioFire Diagnostics, LLC recalls -Outer Kit Box (P/N RFIT-LBL-0140) - FilmArray¿ Meningitis/E

Recalled Product

-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: The FilmArray Meningitis/Encephalitis (ME) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with FilmArray systems.

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: ME Panel Kit Lot No. ME Pouch Lot. No. Kit Expiration Date 580818 892018 4/2/2019 584418 896018 4/5/2019 Note - Kits contain a Primer Pill Lot 210318. The Primer Pill is a freeze dried/lyophilized "pellet" that contains all of the primers and buffer used in the PCR1 reaction.
View official government recall

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