# FDA recall Z-1158-2021

> **BioFire Diagnostics, LLC** · Class II · device recall initiated 2021-01-26.

## Product

BioFire BCID2 Panel; IVD, Rx Only Part No: RFIT-ASY-0147 / UDI: 00815381020338 - Product Usage: intended for use with FilmArray systems.

## Reason for recall

The firm has identified an increased risk of false positive Pseudomonas aeruginosa when BCID/BCID2 Panels are used with specific  BD BACTEC" blood culture vials.

## Distribution

Worldwide distribution - US Nationwide distribution and the countries of Afghanistan, Angola, Anguilla , Argentina, Australia, Austria, Bahrain, Belarus, Belgium, Bolivia, Brazil, Brunei. Daruss., Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Cote d'Ivoire, Croatia, Czech Republic, Dominican Rep, Dutch Antilles, Ecuador, Egypt, El Salvador, Estonia, France, Georgia, Germany, Greece, Guam, Guatemala, Honduras, Hong Kong, Hungary, India, Indonesia, Israel, Italy, Japan, Jordan, Kenya, Kuwait, Latvia, Lebanon, Macedonia, Malaysia, Mexico, Morocco, Myanmar, Netherlands, Nicaragua, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Saudi Arabia, Serbia, Singapore, Slovenia, South Korea, Spain, Sweden, Switzerland, Thailand, Tunisia, Turkey, United Kingdom, Uruguay, Utd/Arab Emir/, Vietnam.

## Key facts

- **Recall number:** Z-1158-2021
- **Recalling firm:** BioFire Diagnostics, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-01-26
- **Report date:** 2021-03-10
- **Termination date:** 2022-05-02

- **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-1158-2021

## Citation

> AI Analytics. FDA recall Z-1158-2021. Retrieved 2026-08-03 from https://api.ai-analytics.org/recall/Z-1158-2021. Source: US FDA. Licensed CC0.

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