Biofire Spotfire Respiratory/Sore Throat Panel recallZ-2081-2026 · BioFire Diagnostics, LLC · initiated Apr 1, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from BioFire Diagnostics, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Respiratory/sore throat panel test may result in false negative results and control failures.
FDA root cause category: Under Investigation by firm
What the company is doing
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 details
- Recall number
- Z-2081-2026
- Status
- Open, Classified
- Initiated by the company
- Apr 1, 2026
- Posted by the FDA
- May 6, 2026
- Recalling firm
- BioFire Diagnostics, LLC
- Quantity
- 2400 pouches
- Product code
- QOF
- FDA submissions
- K232954
- Distribution
- US Nationwide distribution in the states of MS, TX MN, VA.
Product description
Biofire Spotfire Respiratory/Sore Throat Panel REF: 423485
Code information (models, lots, serial numbers)
Lot Number: 2215125/UDI: 00815381020390
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) Panel 423485Biofire Diagnostics, LLC · Bordetella Pertussis Dna Assay System1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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