FDA DeviceClass IINotable

FDA Recall: BioFire Joint Infection (JI) Panel REF: RFIT-ASY-0138, 30 test Kit.

Date: 2026-05-13
Brand: BioFire Diagnostics, LLC
Category: Medical Device
FDA Class: Class II

Description

Contamination to in-vitro diagnostic test may result in false positives.

Hazard

Contamination to in-vitro diagnostic test may result in false positives.

Remedy

106 kits (3,180 test)

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