Device product

FilmArray Pneumonia Panel (Penumo) REF RFIT-ASY-0144

Z-1944-2021

April 16, 2021

Class II

Product summary

Firm: BioFire Diagnostics, LLC
Event: Event 87936
Status: Terminated
Classification: Class II
Quantity: 9 kits (U.S. only)
Official record key: device-enforcement:Z-1944-2021

Official wording

Reason: Elevated rates of false positive/false negative and control failures while using the Pneumonia Panel, due to issues identified in the manufacturing process.

Code information: Part Number:RFIT-ASY-0144 UDI: 00815381020178 Kit Lot#: 0938121 Pouch Lot#: 19T621

Distribution pattern: U.S. Nationwide distribution in the states of MN and OK. O.U.S.: None

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

Elevated rates of false positive/false negative and control failures while using the Pneumonia Panel, due to issues identified in the manufacturing process.