# FDA recall Z-2456-2024

> **BioFire Diagnostics, LLC** · Class II · device recall initiated 2024-06-19.

## Product

BIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF: RFIT-ASY-0147, for FILMARRAY Systems, when used in conjunction with Culture Media Bottles: BACT/ALERT FA PLUS, REF: 410851, and BACT/ALERT PF PLUS, REF: 410853

## Reason for recall

If blood culture identification panel is used in conjunction with specific lots of culture media bottles, then false positive Serratia marcescens results may occur, due to an increased level of non-viable organism from serratia marcescens targets in culture media bottles, false positive result may lead to an inappropriate change in patient therapy.

## Distribution

Worldwide - US Nationwide distribution including in the states of FL, IL, KY, CO, KS, NC, AK, NY, ND, CA, TX, MD, GA, OH, WI, SD, LA, MT, VA, IA, MO, MA, WV, NE, OK, AZ, OR, SC, MI, IN, ID, TN, WA, NM, NJ, AR, AL, MN, NH, NV, PA, WY, MS, CT and the countries of AE, AM, AR, AT, BA, BG, BH, BN, BR, CA, CH, CI, CK, CN, CO, CZ, DE, DZ, EC, EE, EG, ES, FI, FR, GA, GB, GE, GR, GT, HR, HU, IL, IN, IQ, IS, IT, JO, JP, KK, KR, KW, LB, LT, LV, MK, MM, MX, MY, NG, NO, NW, OM, PA, PH, PK, PL, PT, QA, RO, RS, SA, SI, TN, TR, TW, UG, UY, VN, WF.

## Key facts

- **Recall number:** Z-2456-2024
- **Recalling firm:** BioFire Diagnostics, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-06-19
- **Report date:** 2024-08-07

- **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-2456-2024

## Citation

> AI Analytics. FDA recall Z-2456-2024. Retrieved 2026-08-11 from https://api.ai-analytics.org/recall/Z-2456-2024. Source: US FDA. Licensed CC0.

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