FilmArray Pneumonia Panel (Penumo) REF RFIT-ASY-0144
Reported: June 30, 2021 Initiated: April 16, 2021 #Z-1944-2021
Product Description
FilmArray Pneumonia Panel (Penumo) REF RFIT-ASY-0144
Reason for Recall
Elevated rates of false positive/false negative and control failures while using the Pneumonia Panel, due to issues identified in the manufacturing process.
Details
- Recalling Firm
- BioFire Diagnostics, LLC
- Units Affected
- 9 kits (U.S. only)
- Distribution
- U.S. Nationwide distribution in the states of MN and OK. O.U.S.: None
- Location
- Salt Lake City, UT
Frequently Asked Questions
What product was recalled? ▼
FilmArray Pneumonia Panel (Penumo) REF RFIT-ASY-0144. Recalled by BioFire Diagnostics, LLC. Units affected: 9 kits (U.S. only).
Why was this product recalled? ▼
Elevated rates of false positive/false negative and control failures while using the Pneumonia Panel, due to issues identified in the manufacturing process.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 30, 2021. Severity: Moderate. Recall number: Z-1944-2021.
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