medical Class II Updated 2024-01-17

BioFire Diagnostics, LLC recalls The BIOFIRE Respiratory Panel 2.1 (RP2.1) is a PCR-based mul

Recalled Product

The BIOFIRE Respiratory Panel 2.1 (RP2.1) is a PCR-based multiplexed nucleic acid test intended for use with the BIOFIRE FILMARRAY 2.0 or BIOFIRE FILMARRAY Torch Systems.


Hazard / Issue

A manufacturing event may contribute to elevated rates of false negative results while using gastrointestinal panel and respiratory panel, which could lead to inappropriate antibiotic treatment, no treatment, delay of treatment, and may provide false assurance to someone with a true infection, delayed identification of an outbreak, and may result in additional transmission.

Issued by

FDA

Affected States: NC, MO, NE, CT, IL, TN, NJ, OH, MA, CA, FL, UT, IA, KS, TX, MD
Lot/Code Info: UDI-DI: 00815381020529. Kit Lot/Pouch Lot/Expiration: 1667923/2X2423/June 26, 2024; 1890223/2YHT23/July 26, 2024
View official government recall

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