# FDA recall Z-3122-2024

> **BioFire Diagnostics, LLC** · Class II · device recall initiated 2024-08-07.

## Product

FILMARRAY 2.0 INSTRUMENT, REF: FLM2-ASY-0001, FLM2-ASY-0001-W

## Reason for recall

Some automated in vitro diagnostic modules and instruments manufactured or serviced between May 2022 and May 2024 were calibrated with internal equipment that may lead modules and instruments to report higher melting temperatures, which may lead to erroneous results including false positive Salmonella, Giardia lamblia, false positive/negative Norovirus, and false negative MRSA.

## Distribution

Worldwide - US Nationwide distribution including in the states of NC, TX, OH, CA, KS, AL, WA, NY, PA, IL, WI, KY, LA, NE, FL, UT, IA, SC, VA, AZ, CO, WV, MO, TN, MN, DC, DE, OK, WY, IN, NJ, NM, ID, OR, MS, SD, MI, MT, GA, HI, NV, MD, MA, AR, NH, PR, ND, VT, CT, AK, ME, RI and the countries of Korea, Canada, Singapore distributors, Canada, Canada, China, China, Singapore, Canada, China, Mexico, Japan, Chile, Chile, Singapore, Mexico, Hong King, China, Chile, Singapore, Philippines, Korea, Chile, Korea, Australia, Greece.

## Key facts

- **Recall number:** Z-3122-2024
- **Recalling firm:** BioFire Diagnostics, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-08-07
- **Report date:** 2024-09-18

- **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-3122-2024

## Citation

> AI Analytics. FDA recall Z-3122-2024. Retrieved 2026-07-18 from https://api.ai-analytics.org/recall/Z-3122-2024. Source: US FDA. Licensed CC0.

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