FilmArray Pneumonia Panel (Pneumo), REF: RFIT-ASY-0145, For FILMARRAY systems, CE 2797, IVD, Rx Only
Reported: August 30, 2023 Initiated: May 8, 2023 #Z-2440-2023
Product Description
FilmArray Pneumonia Panel (Pneumo), REF: RFIT-ASY-0145, For FILMARRAY systems, CE 2797, IVD, Rx Only
Reason for Recall
Due to manufacturing issue, panels may result in false negative results.
Details
- Recalling Firm
- BioFire Diagnostics, LLC
- Units Affected
- 24 Kits (30 pouches/kit)
- Distribution
- US: CA CO CT FL GA IA IL IN LA MA MI MO MT NC NE NJ NM NY OH OK PA TN UT WV OUS: Canada, India, Japan, Singapore, Colombia
- Location
- Salt Lake City, UT
Frequently Asked Questions
What product was recalled? ▼
FilmArray Pneumonia Panel (Pneumo), REF: RFIT-ASY-0145, For FILMARRAY systems, CE 2797, IVD, Rx Only. Recalled by BioFire Diagnostics, LLC. Units affected: 24 Kits (30 pouches/kit).
Why was this product recalled? ▼
Due to manufacturing issue, panels may result in false negative results.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 30, 2023. Severity: Moderate. Recall number: Z-2440-2023.
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