Recall Z-2683-2024 ยท QDS Mers-Cov And Common Respiratory Pathogens Semi-Quantitative And Quantitative Multiplex Nucleic Acid Detection System
BioFire Diagnostics, LLC
BIOFIRE FILMARRAY Pneumonia Panel plus, REF: RFIT-ASY-0143
| Date | Aug 16, 2024 (initiated Jun 10, 2024) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Nonconforming Material/Component |
| Action | 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. T |
| Quantity | 24 Kits |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.