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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

BioFire Diagnostics, LLC: Due to temperature excursions with products (products being stored outside of the required temperature specifications) that may cause a reduction in performance. The temperature excursion was as a result of shipping delays.

Agency Publication Date: March 15, 2023
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Affected Products

Product: In Vitro Diagnostic (IVD) Panel BioFire BCID2 Panel - REF RFIT-ASY-0147

Part Number: RFIT-ASY-0147 UDI: 0815381020338 Pouch Lot Number: 1766022

Lot Numbers:
Number
Product: In Vitro Diagnostic (IVD) Panel BioFire Respiratory Panel 2.1 (RP2.1) - REF 423742

Part Number: 423742 UDI: 00815381020482 Pouch Lot Number: 1551622

Lot Numbers:
Number
Product: In Vitro Diagnostic (IVD) Panel FilmArray GI Panel - REF RFIT-ASY-0116

Part Number: RFIT-ASY-0116 UDI: 00815381020109 Pouch Lot Number: 1674322

Lot Numbers:
Number

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 91647
Status: Active
Manufacturer: BioFire Diagnostics, LLC
Manufactured In: United States
Units Affected: 3 products (2 kits; 8 kits; 2 kits)

Were You Affected by This Recall?

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.