Z-1903-2021 Class II Terminated
FDA device recall Z-1903-2021 was initiated by BioFire Diagnostics, LLC on May 10, 2021 and is designated Class II. Reason for recall: Elevated rates of false negative results may occur when using blood culture panels due to issues in the manufacturing process. Pouches contained OPP from FilmArray Blood Culture Identification Panel (… The recall status is terminated (terminated December 15, 2022). Affected quantity: 870 kits.
Recall Details
- Product Type
- Devices
- Report Date
- June 30, 2021
- Initiation Date
- May 10, 2021
- Termination Date
- December 15, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 870 kits
Product Description
BioFire BCID2 Panel, REF RFIT-ASY-0147, For FilmArray Systems, CE, Blood Culture Identification Panel in vitro diagnostic, Rx Only, UDI: (01)00815381020338
Reason for Recall
Elevated rates of false negative results may occur when using blood culture panels due to issues in the manufacturing process. Pouches contained OPP from FilmArray Blood Culture Identification Panel (BCID) instead of OPP from BCID2 Panel.
Distribution Pattern
US nationwide distribution
Code Information
Pouch Lot# 11YA20/ Kit Lot# 2039020. UDI: (01)00815381020338