medical MODERATE Updated 2026-05-13

BioFire Diagnostics, LLC recalls Biofire Spotfire Respiratory/Sore Throat Panel REF: 423485

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Recalled Product

Biofire Spotfire Respiratory/Sore Throat Panel REF: 423485

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Hazard / Issue

Respiratory/sore throat panel test may result in false negative results and control failures.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot Number: 2215125/UDI: 00815381020390

✅ 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.

Looking for a safe alternative?

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View official government recall

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