FilmArray Pneumonia Panel Plus (Pneumoplus), REF: RFIT-ASY-0143, CED 2797, IVD, Rx Only (30 test kit)
Reported: February 14, 2024 Initiated: December 14, 2023 #Z-0993-2024
Product Description
FilmArray Pneumonia Panel Plus (Pneumoplus), REF: RFIT-ASY-0143, CED 2797, IVD, Rx Only (30 test kit)
Reason for Recall
Their is a potential for false positive results when using Pneumonia panel.
Details
- Recalling Firm
- BioFire Diagnostics, LLC
- Units Affected
- 214,080 pouches
- Distribution
- Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY and the countries of Argentina, Bolivia, Brazil, Chili, China, Colombia, Costa Rica, Dominican Republic, Ecuador, Guatemala, Hong Kong, Honduras, Japan, South Korea, Mexico, Nicaragua, Panama, Peru, Philippines, Paraguay, Singapore, El Salvador, Thailand, Taiwan, Uruguay, Venezuela.
- Location
- Salt Lake City, UT
Frequently Asked Questions
What product was recalled? ▼
FilmArray Pneumonia Panel Plus (Pneumoplus), REF: RFIT-ASY-0143, CED 2797, IVD, Rx Only (30 test kit). Recalled by BioFire Diagnostics, LLC. Units affected: 214,080 pouches.
Why was this product recalled? ▼
Their is a potential for false positive results when using Pneumonia panel.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 14, 2024. Severity: Moderate. Recall number: Z-0993-2024.
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