Reported Nov 21, 2018 · Terminated
-Outer Kit Box (P/N RFIT-LBL-0140) - FilmArray¿ Meningitis/Encephalitis (ME) Panel REF RFIT-ASY-0118 30 For FilmArray…
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?
- -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 UsageThe FilmArray Meningitis/Encephalitis (ME) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with FilmArray systems
- Lot codes and dates
- 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.
- Amount recalled
- 1350 pouches
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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