Class II U.S. Food and Drug Administration

Biofire Spotfire recall: Respiratory/sore throat panel test may result in false negative results

Recall published 6 months ago

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

The hazard: Device malfunction

A malfunction was identified in this device. What matters most is whether your particular unit falls inside the affected model, lot or serial range.

What the notice says: Respiratory/sore throat panel test may result in false negative results and control failures.

Why it matters: The device may not perform as intended — a mechanical failure, a software defect, an inaccurate reading, or an alarm that does not sound. For a device someone depends on, the consequence of the failure is usually worse than the failure itself.

Symptoms and when to call a doctor

If the device supports a vital function, do not disable or remove it on your own judgement. Contact the clinician who prescribed or fitted it, and use the back-up arrangement they gave you. Go to an emergency department if the symptoms the device is meant to manage are getting worse, or if an implanted device gives an unexpected alarm or shock.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Recall number
Z-2081-2026
Published
May 13, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
BioFire Diagnostics, LLC
Product type
Medical devices
Units affected
2400 pouches
Distribution
Nationwide
Made in
United States
Lot / code info
Lot Number: 2215125/UDI: 00815381020390
UPC codes
00815381020390

Products covered by this recall

Biofire Spotfire Respiratory/Sore Throat Panel REF: 423485

Check your product

The notice names 3 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 00815381020390

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • 2215125
  • UDI

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Malfunction

BioFire Diagnostics, LLC — A malfunction was identified in this device. What matters most is whether your particular unit falls inside the affected model, lot or serial range.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers listed on this page.
  2. If the device is implanted, or you depend on it daily, speak to your clinician before changing anything about how you use it.
  3. Check whether the remedy is a software update, and if so confirm afterwards in the device menu that the version actually changed.
  4. If you are a clinic or facility, quarantine affected stock and record the correction in your recall log.

Who pays for a device recall

The manufacturer funds the remedy. The practical question is usually which link in the chain executes it.

  • If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.
  • Ask for written confirmation that the remedy was applied to your serial number. That is what an insurer or a future clinician will want to see.
  • If you bought it yourself online or from a pharmacy, go to the manufacturer’s recall page rather than the retailer; device claims are handled centrally.
  • Where the remedy is a software update, there is nothing to claim, but do confirm the version changed afterwards.

Company contact: BioFire Diagnostics, LLC — 515 S Colorow Dr, Salt Lake City, UT, 84108-1248

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was BioFire Diagnostics, LLC medical devices recalled?

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

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 00815381020390; lot code 2215125, UDI. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers listed on this page.

Can I get my money back?

If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.

Where was the recalled product sold?

It was distributed nationwide.

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