# FDA recall Z-0446-2019

> **BioFire Diagnostics, LLC** · Class II · device recall initiated 2018-09-10.

## Product

-Outer Kit Box (P/N RFIT-LBL-0140) - FilmArray¿ Meningitis/Encephalitis (ME) Panel  REF RFIT-ASY-0118  30  For FilmArray systems   LOT  KIT UDI (01)00815381020123  CE 0086 IVD      -Fitment Label (P/N RFIT-LBL-0138)  which identifies the pouch label - FilmArray¿ ME Panel v1.4  LOT  SN  CE 0086  IVD      Product Usage:  The FilmArray Meningitis/Encephalitis (ME) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with FilmArray systems.

## Reason for recall

Firm identified an issue in the manufacturing process which might contribute to elevated rates of false positive results for HSV-1 while using the ME Panel. Only specific kits are affected.

## Distribution

Worldwide Distribution - US Nationwide in the states of:  CA DC, FL, IN, KY, MN, MO, NB, NJ, OH, TX and WI.    International: Canada, Columbia and Mexico

## Key facts

- **Recall number:** Z-0446-2019
- **Recalling firm:** BioFire Diagnostics, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-09-10
- **Report date:** 2018-11-21
- **Termination date:** 2021-04-28

- **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-0446-2019

## Citation

> AI Analytics. FDA recall Z-0446-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-0446-2019. Source: US FDA. Licensed CC0.

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