FilmArray Pneumonia Panel (Penumo) REF RFIT-ASY-0144
- Company
- Biofire Diagnostics, Llc
- Recall Initiated
- April 16, 2021
- Terminated
- April 2, 2024
- Recall Number
- Z-1944-2021
- Quantity
- 9 kits (U.S. only)
- Firm Location
- Salt Lake City, UT
Reason for Recall
Elevated rates of false positive/false negative and control failures while using the Pneumonia Panel, due to issues identified in the manufacturing process.
Distribution
U.S. Nationwide distribution in the states of MN and OK. O.U.S.: None
Lot / Code Info
Part Number:RFIT-ASY-0144 UDI: 00815381020178 Kit Lot#: 0938121 Pouch Lot#: 19T621
Root Cause
Under Investigation by firm
Action Taken
On 04/16/2021, the firm sent an "URGENT: MEDICAL DEVICE RECALL" Notification Letter via email informing its customers of an issue identified in the manufacturing process which might contribute to elevated rates of false positive/false negative results and control failures while using the pneumonia panel. Customer are instructed to: 1) Immediately examine their inventory for product identified in this recall. 2) Discontinue use and discard any remaining product in their possession that is subject to this recall. The Recalling Firm will replace the product at no charge in accordance with its standard limited warranty. 3) Confirm the amount of pouches scrapped (if any) on the attached Acknowledgement of Receipt Form. 4) If the affected products have been further distributed, customers are to identify any recipients and notify them at once of this product recall. 5) Complete the accompanying Field Action Acknowledgment of Receipt Form and return to Recalling Firm so that it may acknowledge their receipt of this notification. For questions or concerns contact Customer Support Department at Support@biofiredx.com or via telephone 1-800-735-6544, option 5 for Product Technical Support.