BIOFIRE FILMARRAY Pneumonia Panel plus, REF: RFIT-ASY-0143
- Company
- Biofire Diagnostics, Llc
- Recall Initiated
- June 10, 2024
- Posted
- August 16, 2024
- Recall Number
- Z-2683-2024
- Quantity
- 24 Kits
- Firm Location
- Salt Lake City, UT
Reason for Recall
Pneumonia panels have an increased risk of control failures due to an issue in the manufacturing process, which could lead to delayed results for the customer.
Distribution
Worldwide - US Nationwide distribution in the states of WV, IN, AL and the countries of France, Italia, Spain, Greece, Japan Ltd, Singapore, Chile, Taiwan, Israel, Romania, Ecuador, Serbia.
Lot / Code Info
UDI-DI: 00815381020314. Lot/Expiration: 2147723/27-Aug-2024
Root Cause
Nonconforming Material/Component
Action Taken
On 6/10/24, field safety notices were sent to laboratory managers who were informed of the following: Discontinue use and discard any remaining product in your possession. If you have further distributed this product, please identify any recipients, and notify them at once. Complete and return the Acknowledgement of Receipt Form and return via email to usfieldactions@biomerieux.com If you have questions, please contact your firm's local US Commercial Operations. at (800) 682-2666. For non-urgent inquiries, please contact the Technical Support Center by email at BioFireSupport@biomerieux.com. The anticipated turnaround time for email inquiries is 24 - 48 hours during normal business hours.