BioFire Respiratory Panel 2.1, IVD, REF: 423742 (30 test… recallZ-0602-2026 · BioFire Diagnostics, LLC · initiated Oct 22, 2025
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
Due to unintended movement of pouch chemistry, nucleic acid test may result in elevated risk of false negative results and risk of control failures.
FDA root cause category: Under Investigation by firm
What the company is doing
On May 28, 2026, Biomerieux issued a "Urgent: Medical Device Recall" Expansion Notification to affected consignees via E-Mail. Initial notification was sent out on October 22, 2025. Biomerieux asked consignees to take the following actions: 1. Examine your inventory for the lot identified in this field safety notice. 2. Discontinue use and discard any remaining product from this lot in your possession. 3. Please confirm the quantity of kits that have been destroyed, previously used, or returned on the attached Acknowledgement of Receipt Form. 4. If you have further distributed this product, please identify any recipients and notify them at once. 5. Please complete the accompanying Acknowledgement of Receipt Form and return to bioMrieux so that bioMrieux may acknowledge your receipt of this notification. 6. Complete and submit the report online. Regular Mail or Fax: Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form or submit by fax to 1-800-FDA-0178.
Recall details
- Recall number
- Z-0602-2026
- Status
- Open, Classified
- Initiated by the company
- Oct 22, 2025
- Posted by the FDA
- Nov 26, 2025
- Recalling firm
- BioFire Diagnostics, LLC
- Quantity
- 97 Kits (2,910 pouches)
- Product code
- QOF
- Distribution
- US:AZ, FL,GA,ID NC, NH, NJ, NY, OR, PA, SC OUS: None
Product description
BioFire Respiratory Panel 2.1, IVD, REF: 423742 (30 test kit)
Code information (models, lots, serial numbers)
UDI: 00815381020529 /Lot # 2649724 Expanded Lot#: 1471725
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- BioFire® Respiratory Panel 2.1 423742Biofire Diagnostics, LLC · Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents3 recalls4 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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