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FDA · Medical device recall

Biofire Spotfire Respiratory/Sore Throat Panel REF: 423485

Recall started · FDA enforcement report May 13, 2026 Class II

Reason
Respiratory/sore throat panel test may result in false negative results and control failures.
Status
Ongoing
Distribution
US Nationwide distribution in the states of MS, TX MN, VA.

This box checks this one record only. Other recalls of the same product or company are on the brand page.

Enforcement report date
May 13, 2026
Risk class
Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)
Status
Ongoing (FDA's definition: a recall which is currently in progress; as in openFDA's data of Nov. 10, 2026)
Filed by
BioFire Diagnostics, LLC
Product
Biofire Spotfire Respiratory/Sore Throat Panel REF: 423485
Reason
Respiratory/sore throat panel test may result in false negative results and control failures.
Distribution pattern
US Nationwide distribution in the states of MS, TX MN, VA.
Quantity
2400 pouches
Codes and lots
Lot Number: 2215125/UDI: 00815381020390
Recall started
April 1, 2026
Voluntary or mandated
Voluntary: Firm initiated
Device type
Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents
Root cause (FDA)
Under Investigation by firm
What the company told customers
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.
Recall number
Z-2081-2026

What the record says about this device

A simplified drawing of a device, following the words of FDA's record. It shows the reason the record gives, not a photograph of the product.

Four steps: a device, the reason the record gives, the record's wordsA simplified drawing of a medical device with a mark for the reason the record gives. Left, for comparison: the same drawing without what the record names. Right: this record.1 The product: Biofire Spotfire Respiratory/Sore…2 The record describes a result that wrongly reads negative or low3 What the record says4 What the record lists−?−?FOR COMPARISONthe same drawing, withoutwhat the record namesTHIS RECORDwhat the record names,step by stepfalse negative

“Respiratory/sore throat panel test may result in false negative results and control failures.”Biofire Spotfire Respiratory/Sore Throat Panel REF: 423485, FDA enforcement report, 2026-05-13. The caption is the record's own words.

A generic device, not the product. The mark follows the record's own words.

If the drawing and the record's words differ, the words govern. A drawing is chosen by rules and an AI reading of the record and can miss what it means; report one with the form below.

FDA device name: Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents

Distributed in (FDA's record): Minnesota Mississippi Texas Virginia and nationwide

This recall among the others

  • FDA's enforcement report came 42 days after the firm started the recall. For half of the 860 FDA medical device recall events reported in 2026 so far with a start date, it took 49 days or fewer (by year).
  • BioFire Diagnostics: 15 other recalls or notices on this site in the three years before this one (from May 14, 2023).

Counted from the agency records on this site, as on Statistics: a recall event once, by its first notice.

What should I do? How serious is a recall? Classes and warnings explained · How to read this record

Source: FDA · Medical device enforcement report, recall number Z-2081-2026. See this record in openFDA (FDA's own data service; it answers in JSON). The agency record governs; check it and the company before acting.

Cite this record
FDA recall record Z-2081-2026, May 13, 2026. "Biofire Spotfire Respiratory/Sore Throat Panel REF: 423485." PlainRecords, https://plainrecords.com/recall/device/z-2081-2026/ (as of the day it was built).

At each build a sample of records from each source is compared with the agency's published file and the page; every correction is public. Drawings are chosen by software that reads the record. Built daily. How we check · Corrections

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