# FDA recall Z-2040-2021

> **BioFire Diagnostics, LLC** · Class II · device recall initiated 2021-06-07.

## Product

FilmArray Pneumonia Panel plus (Pneumoplus)    Part Numbers:  Part No: RFIT-ASY-0143 / UDI: 00815381020314 (30 test kit)  Part No: RFIT-ASY-0142 / UDI: 00815381020321 (6 test kit)

## Reason for recall

Due to real-time stability study failures resulting in increase rate of false negative results between the 6 to 12 month expiry time-frame.

## Distribution

U.S.: AK, AL, AZ, CA, CA, CO, CT, DC, DE, FL, GA, Guam, HI, IA, ID, IL, IN, IN, KS, KY, KY, LA, MA, MD, ME, MI, MI, MN, MO, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, SC, TN, TX, UT, VA, VT, WA, WI, WV and WY.    O.U.S.: Algeria, Angola, Anguilla, Argentina, Australia, Austria, Bahrain, Belarus, Belgium, Bermuda, Bolivia, Bosnia-Herz., Brazil, Bulgaria, Chile, China, Colombia, Costa Rica, Cote d'Ivoire, Croatia, Czech Republic, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, France, Georgia, Germany, Greece , Guatemala, Honduras, Hong Kong, Hungary, India, Indonesia, Iraq, Israel, Italy, Japan, Jordan, Kenya, Kuwait, Latvia, Lebanon, Lithuania, Macedonia, Malaysia, Mexico, Morocco, Myanmar, Nepal, Netherlands, Nicaragua, Oman, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Saudi Arabia, Serbia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Thailand, Tunisia, Turkey, United Kingdom, Uruguay, United Arab Emirate

## Key facts

- **Recall number:** Z-2040-2021
- **Recalling firm:** BioFire Diagnostics, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-06-07
- **Report date:** 2021-07-14
- **Termination date:** 2023-07-31

- **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-2040-2021

## Citation

> AI Analytics. FDA recall Z-2040-2021. Retrieved 2026-06-30 from https://api.ai-analytics.org/recall/Z-2040-2021. Source: US FDA. Licensed CC0.

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