Z-0602-2026Class II

BioFire Respiratory Panel 2.1, IVD, REF: 423742 (30 test kit)

Name: Z-0602-2026 BioFire Respiratory Panel 2.1, IVD, REF: 423742 (30 test kit)
Creator: BioFire Diagnostics, LLC
Published: 2025-10-22
License: https://open.fda.gov/license/

BioFire Diagnostics, LLC / initiated 2025-10-22 / Open, Classified / root cause: packaging

FDA source

BioFire Diagnostics, LLC began a recall of BioFire Respiratory Panel 2.1, IVD, REF: 423742 (30 test kit) on 2025-10-22. FDA classified it as Class II and gives the reason as "Due to unintended movement of pouch chemistry, nucleic acid test may result in elevated risk of false negative results and risk of control failures". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0602-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-10-22
Posted: 2025-11-26
Recalling firm: BioFire Diagnostics, LLC
Product: BioFire Respiratory Panel 2.1, IVD, REF: 423742 (30 test kit)
Product code: QOF Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents
Reason for recall: Due to unintended movement of pouch chemistry, nucleic acid test may result in elevated risk of false negative results and risk of control failures.
Root cause tag: packaging
FDA root cause: Under Investigation by firm
Action: 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.
Quantity in commerce: 97 Kits (2,910 pouches)
Distribution: US:AZ, FL,GA,ID NC, NH, NJ, NY, OR, PA, SC OUS: None
Product codes and lots: UDI: 00815381020529 /Lot # 2649724 Expanded Lot#: 1471725

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0602-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0602-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-12-03	2025-11-26

Product code QOF

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)