BioFire Respiratory Panel 2.1 plus Kit, REF: 423740, For Filmarray systems
FDA device recall Z-1877-2025 · posted 2025-05-29 · Open, Classified
Recall details
- Recalling firm
- BioFire Diagnostics, LLC
- Reason for recall
- Due to manufacturing error, respiratory panel may result in elevated control failures and/or false negative results.
- Action taken
- 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.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- OCC
- Quantity affected
- 30 kits
- Distribution
- International distribution in the country of Singapore.
- Date initiated
- 2025-04-30
- Date posted
- 2025-05-29
- Location
- Salt Lake City, UT
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.