CLASS II ONGOING Device recall · Reported 19 Aug 2026 · FDA Enforcement Report

Biofire Respiratory Panel 1 (RP2.1) recalled by BioFire Diagnostics

BioFire Diagnostics is recalling Biofire Respiratory Panel 1 (RP2.1), distributed nationwide in the US. The recall was initiated on 24 Jun 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesPart Number: 423742 UDI-DI code: 00815381020529 Pouch Lot: 3VLB25 Kit Lot: 1872125
Quantity recalled2,370 pouches (79 kits)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number
Z-2936-2026
FDA event ID
99261
Recalling firm
BioFire Diagnostics, Salt Lake City, UT
Classification
Class II
Status
Ongoing
Recall initiated
24 Jun 2026
FDA classified
12 Aug 2026
Reported
19 Aug 2026
Type
Voluntary: Firm initiated
Reason category
Other Reasons

Timeline

24 Jun 2026Recall initiated by company
12 Aug 2026Classified by FDA+49 days
19 Aug 2026Published in enforcement report+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Due to increase in false negative results

Product as listed by the FDA

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

Where it was distributed

U.S. Nationwide distribution in the states of AL, AR, IA, IL, KS, LA, MN, MO, TX, and WI.

Nationwide AlabamaArkansasIowaIllinoisKansasLouisianaMinnesotaMissouriTexasWisconsin

Questions about this recall

Is Biofire Respiratory Panel 1 (RP2.1) recalled?

Yes. BioFire Diagnostics recalled Biofire Respiratory Panel 1 (RP2.1) on 24 Jun 2026. The recall is Class II and its status is Ongoing. Recall number Z-2936-2026.

Why was it recalled?

Due to increase in false negative results

Which lots are affected?

Part Number: 423742 UDI-DI code: 00815381020529 Pouch Lot: 3VLB25 Kit Lot: 1872125

Where was it sold?

U.S. Nationwide distribution in the states of AL, AR, IA, IL, KS, LA, MN, MO, TX, and WI.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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