BioFire Respiratory Panel 2.1 plus Kit, REF: 423740, For Filmarray systems
- Company
- Biofire Diagnostics, Llc
- Recall Initiated
- April 30, 2025
- Posted
- May 29, 2025
- Recall Number
- Z-1877-2025
- Quantity
- 30 kits
- Firm Location
- Salt Lake City, UT
Reason for Recall
Due to manufacturing error, respiratory panel may result in elevated control failures and/or false negative results.
Distribution
International distribution in the country of Singapore.
Lot / Code Info
Lot# 1475424/ UDI: None
Root Cause
Under Investigation by firm
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.