Z-2081-2026Class II

Biofire Spotfire Respiratory/Sore Throat Panel REF: 423485

Name: Z-2081-2026 Biofire Spotfire Respiratory/Sore Throat Panel REF: 423485
Creator: BioFire Diagnostics, LLC
Published: 2026-04-01
License: https://open.fda.gov/license/

BioFire Diagnostics, LLC / initiated 2026-04-01 / Open, Classified

FDA source

BioFire Diagnostics, LLC began a recall of Biofire Spotfire Respiratory/Sore Throat Panel REF: 423485 on 2026-04-01. FDA classified it as Class II and gives the reason as "Respiratory/sore throat panel test may result in false negative results and control failures". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2081-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-04-01
Posted: 2026-05-06
Recalling firm: BioFire Diagnostics, LLC
Product: Biofire Spotfire Respiratory/Sore Throat Panel REF: 423485
Product code: QOF Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents
Reason for recall: Respiratory/sore throat panel test may result in false negative results and control failures.
FDA root cause: Under Investigation by firm
Action: On April 1, 2026, Biomerieux, issued a "Urgent Medical Device Recall" via E-Mail. Biomerieux ask consignees to take the following actions: In this context, we request that you take the following actions: " Examine your inventory for the lot identified in this recall notice. "Discontinue use and discard any remaining product from this lot in your possession. "Please confirm the quantity of kits that have been destroyed, previously used, or returned on the attached Acknowledgement of Receipt Form. "If you have further distributed this product, please identify any recipients and notify them at once. " Please complete the accompanying Acknowledgement of Receipt Form and return to bioMrieux.
Quantity in commerce: 2400 pouches
Distribution: US Nationwide distribution in the states of MS, TX MN, VA.
Product codes and lots: Lot Number: 2215125/UDI: 00815381020390

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2081-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2081-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-05-13	2026-05-06

Product code QOF

K232954Class IIBIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) PanelBiofire Diagnostics, LLC / cleared 2024-03-26

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)