BioFire Diagnostics, LLC: Medical Device Recall in 2021 - (Recall #: Z-2245-2021)

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:

FilmArray Blood Culture Identification (BCID) Panel Product Pouch Label: FilmArray BCID Panel Part No: RFIT-ASY-0126 Part No: RFIT-ASY-0127

Product Classification:

Class II

Date Initiated: July 20, 2021

Date Posted: August 18, 2021

Recall Number: Z-2245-2021

Event ID: 88410

Reason for Recall:

Due to product complaints received for false negative results (dropouts) with blood culture identification panel potential caused by a pouch manufacturing error.

Status: Terminated

Product Quantity: 29 kits

Code Information:

Part No: RFIT-ASY-0126 / UDI: 00815381020086; Part No: RFIT-ASY-0127 / UDI: 00815381020093; Kit Lot# 0868221; Pouch Lot# 194Z21; Batch 003

Distribution Pattern:

U.S. Nationwide Distribution in the states of : FL, MI, NJ, OH, VA and WI. O.U.S.: None

Voluntary or Mandated:

Voluntary: Firm initiated