Product Safety Recalls

Product Recall Tracker

BioFire Diagnostics, LLC Recall 87936

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

BioFire Diagnostics, LLC Recall 87936 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-1944-2021
Event ID87936
Event DescriptionFilmArray Pneumonia Panel (Penumo) REF RFIT-ASY-0144
Product TypeDevices
DistributionU.S. Nationwide distribution in the states of MN and OK. O.U.S.: None
Quantity9 kits (U.S. only)
Recall ReasonElevated rates of false positive/false negative and control failures while using the Pneumonia Panel, due to issues identified in the manufacturing process.
Device Classification20210630
Device Code InfoPart Number:RFIT-ASY-0144 UDI: 00815381020178 Kit Lot#: 0938121 Pouch Lot#: 19T621
Center Classification Date20210624
Recall Initiation Date20210416
Recalling FirmBioFire Diagnostics, LLC
Initial Notification Letter
Similar To

© 2022 Recall.Report / Contact / Privacy Policy

This site's data is aggregated programmatically and provided "as is" without any representations or warranties, express or implied. is not affiliated with the Consumer Product Safety Commision, FDA, or US government in any way.