-Outer Kit Box — Class II medical device recall Z-0446-2019

Terminated recall by BioFire Diagnostics, LLC, reported 2018-11-21, distributed nationwide. Firm identified an issue in the manufacturing process which might contribute to elevated rates of false positi

Recall number	`Z-0446-2019`
Product type	Medical device
Classification	Class II
Status	Terminated
Voluntary or mandated	Voluntary
Recalling firm	BioFire Diagnostics, LLC, Salt Lake City, UT, United States
Recall initiated	2018-09-10
Classified	2018-11-09
Reported by FDA	2018-11-21
Terminated	2021-04-28
Distributed	Nationwide (US)
Countries outside the US	CA, MX
Quantity	1,350 pouches
UPC / GTIN / UDI-DI	`00815381020123`
Lot numbers	`0086IVD`, `210318`, `580818`, `584418`, `892018`, `896018`
Model numbers	`RFIT-ASY-0118`

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0446-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.