# FDA recall Z-2295-2020

> **BioFire Diagnostics, LLC** · Class II · device recall initiated 2020-01-22.

## Product

FilmArray BCID Panel, RFIT-ASY-0126, 30, Rx Only, CE, IVD,  UDI:  00815381020086 used with the following BACT/ALERT Blood Culture Bottle Catalog No./Description:      410851/BACT/ALERT¿ FA Plus  410852/BACT/ALERT¿ FN Plus  410853/BACT/ALERT¿ PF Plus  259790/BACT/ALERT¿ SN    Product Usage: is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with FilmArray systems.

## Reason for recall

There is an increased risk of false positive Proteus results when using the Film Array Blood Culture Identification Panel (BCID) in vitro diagnostic test of blood cultures used in conjunction with specific media types. False positive Proteus results from this test may lead to patients receiving improper antibiotic treatment until culture results are available (within 24-48 hours).

## Distribution

Worldwide distribution - US Nationwide distribution and the countries of Argentina, Austria, Australia, Azerbaijan, Belgium, Bosnia-Herz., Botswana, Brazil, Bulgaria, Burkina Faso, Canada, Chile, Columbia, Costa Rica, Croatia, Czech Republic, Dominican Republic, Dutch Antilles, Ecuador, Egypt, El Salvador, Estonia, France, Gabon, Georgia, Germany, Greece, Guam, Guatemala, Honduras, Hong Kong, Hungary, India, Indonesia, Iraq, Israel, Italy, Ivory Coast, Japan, Kenya, Kuwait, Latvia, Lebanon, Lithuania, Malaysia, Mexico, Morocco, Myanmar, Netherlands, Nicaragua, Oman, Pakistan, Panama, Paraguay, Peru, Phillipines, Poland, Portugal, Romania, Saudi Arabia, Serbia, Singapore, Slovenia, South Africa, South Korea, Spain, Sweden, Sitzerland, Thailand, Tunisia, Turkey, United Kingdom, Uruguay, United Arab Emirates, Vietnam.

## Key facts

- **Recall number:** Z-2295-2020
- **Recalling firm:** BioFire Diagnostics, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-01-22
- **Report date:** 2020-06-17
- **Termination date:** 2021-04-14

- **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-2295-2020

## Citation

> AI Analytics. FDA recall Z-2295-2020. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/Z-2295-2020. Source: US FDA. Licensed CC0.

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