Device 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.
Z-0704-2024
Product summary
- Event
- Event 93526
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 57 Kits
- Official record key
device-enforcement:Z-0704-2024
Official wording
Reason: 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.
Code information: UDI-DI: 00815381020529. Kit Lot/Pouch Lot/Expiration: 1667923/2X2423/June 26, 2024; 1890223/2YHT23/July 26, 2024
Distribution pattern: US: NC, MO, NE, CT, IL, TN, NJ, OH, MA, CA, FL, UT, IA, KS, TX, MD
Derived failure modes
-
Unknown
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.