BioFire Diagnostics, LLC: Medical Device Recall in 2021 - (Recall #: Z-1903-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

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

Product Classification:

Class II

Date Initiated: May 10, 2021

Date Posted: June 30, 2021

Recall Number: Z-1903-2021

Event ID: 87934

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.

Status: Terminated

Product Quantity: 870 kits

Code Information:

Pouch Lot# 11YA20/ Kit Lot# 2039020. UDI: (01)00815381020338

Distribution Pattern:

US nationwide distribution

Voluntary or Mandated:

Voluntary: Firm initiated