Z-1877-2025Class II

BioFire Respiratory Panel 2.1 plus Kit, REF: 423740, For Filmarray systems

Name: Z-1877-2025 BioFire Respiratory Panel 2.1 plus Kit, REF: 423740, For Filmarray systems
Creator: BioFire Diagnostics, LLC
Published: 2025-04-30
License: https://open.fda.gov/license/

BioFire Diagnostics, LLC / initiated 2025-04-30 / Open, Classified / root cause: manufacturing process

FDA source

BioFire Diagnostics, LLC began a recall of BioFire Respiratory Panel 2.1 plus Kit, REF: 423740, For Filmarray systems on 2025-04-30. FDA classified it as Class II and gives the reason as "Due to manufacturing error, respiratory panel may result in elevated control failures and/or false negative results". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1877-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-04-30
Posted: 2025-05-29
Recalling firm: BioFire Diagnostics, LLC
Product: BioFire Respiratory Panel 2.1 plus Kit, REF: 423740, For Filmarray systems
Product code: OCC Respiratory Virus Panel Nucleic Acid Assay System
Reason for recall: Due to manufacturing error, respiratory panel may result in elevated control failures and/or false negative results.
Root cause tag: manufacturing process
FDA root cause: Under Investigation by firm
Action: On April 30, 2025, Biomerieux issued a "Urgent Field Safety Notice" to affected consignees via email. Biomerieux asked consignees to take the following actions: 1. Immediately 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. As previously confirmed discontinued use of product, please confirm the amount of kits destroyed 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.
Quantity in commerce: 30 kits
Distribution: International distribution in the country of Singapore.
Product codes and lots: Lot# 1475424/ UDI: None

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1877-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1877-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-06-04	2025-05-29

Product code OCC

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)