medical MODERATE Updated 2026-05-13

BioFire Diagnostics, LLC recalls BioFire Joint Infection (JI) Panel REF: RFIT-ASY-0138, 30 t

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Recalled Product

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

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Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot #s:0883425,0878825/DI: 00815381020192

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.

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