Class II U.S. Food and Drug Administration

Biofire Respiratory Panel 2.1 REF 423742 UDI code: 00815381020529 recall: Due to increase in false negative results

Recall published 2 months ago

Due to increase in false negative results

The hazard: Device malfunction

This is a device recall, and in FDA language that usually means a correction rather than a removal: the device stays in use and the manufacturer fixes, patches or re-instructs.

What the notice says: Due to increase in false negative results

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-2936-2026
Published
August 19, 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
2,370 pouches (79 kits)
Distribution
Nationwide
Made in
United States
Lot / code info
Part Number: 423742 UDI-DI code: 00815381020529 Pouch Lot: 3VLB25 Kit Lot: 1872125
UPC codes
00815381020529

Products covered by this recall

BIOFIRE Respiratory Panel 2.1 (RP2.1) REF 423742 UDI code: 00815381020529 PCR-based multiplexed nucleic acid test, in vitro diagnostic

Check your product

The notice names 2 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.

  • 00815381020529

Lot or batch code

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

  • 3VLB25 Kit Lot

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 — This is a device recall, and in FDA language that usually means a correction rather than a removal: the device stays in use and the manufacturer fixes, patches or re-instructs.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers listed on this page.
  2. Check whether the remedy is a software update, and if so confirm afterwards in the device menu that the version actually changed.
  3. If you are a clinic or facility, quarantine affected stock and record the correction in your recall log.
  4. Report device problems to the FDA through MedWatch — that database is where this recall came from.

Replacements, repairs and reimbursement

Device remedies run through the supply chain, so the route depends on who sold you the unit.

  • Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.
  • If the device was billed to insurance or Medicare, the replacement is usually billed the same way; you should not face a second deductible for a recall.
  • Keep every piece of correspondence. If a recalled device caused harm, that paper trail is what a claim rests on.
  • Consumer-purchased devices such as monitors and test kits are normally replaced free, with return shipping paid.

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?

Due to increase in false negative results Due to increase in false negative results

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 00815381020529; lot code 3VLB25 Kit Lot. 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?

Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.

Where was the recalled product sold?

It was distributed nationwide.

Related recalls