BioFire Diagnostics, LLC: Medical Device Recall in 2018 - (Recall #: Z-0296-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

FilmArray Blood Culture Identification (BCID), IVD, Rx Only, BioFire Diagnostics, LLC, Panel Catalog Numbers/ UDI: RFIT-ASY-0126 (30 test kit)/ 00815381020086, RFIT-ASY-0127 (6 test kit)/ 00815381020093, when used with the following blood culture bottles: Bottle Description/Part Number: BACT/ALERT FA Plus/ 410851, BACT/ALERT FN Plus/ 410852, BACT/ALERT PF Plus/ 410853,

Product Classification:

Class II

Date Initiated: September 5, 2018

Date Posted: November 7, 2018

Recall Number: Z-0296-2019

Event ID: 81060

Reason for Recall:

Increased risk of false positive results for Proteus when the product is used with a specific blood culture bottles.

Status: Terminated

Product Quantity: 18038

Code Information:

All lots.

Distribution Pattern:

Worldwide distribution. US nationwide, Kuwait, Lebanon, Malaysia, Myanmar, Nicaragua, Oman, Panama, Paraguay, Peru, Philippines, Qatar, Romania, Saudi Arabia, Slovenia, Uruguay, United Arab Emirates, Vietnam

Voluntary or Mandated:

Voluntary: Firm initiated