# FDA recall Z-0296-2019

> **BioFire Diagnostics, LLC** · Class II · device recall initiated 2018-09-05.

## Product

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,

## Reason for recall

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

## Distribution

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

## Key facts

- **Recall number:** Z-0296-2019
- **Recalling firm:** BioFire Diagnostics, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-09-05
- **Report date:** 2018-11-07
- **Termination date:** 2021-03-22

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Salt Lake City, UT, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0296-2019

## Citation

> AI Analytics. FDA recall Z-0296-2019. Retrieved 2026-07-07 from https://api.ai-analytics.org/recall/Z-0296-2019. Source: US FDA. Licensed CC0.

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