FDA Medical Device Recalls (openFDA)
BioFire Diagnostics, LLC: FilmArray Pneumonia Panel (Penumo) REF RFIT-ASY-0144
- Recall number
- Z-1944-2021
- Recalling firm
- BioFire Diagnostics, LLC
- Product
- FilmArray Pneumonia Panel (Penumo) REF RFIT-ASY-0144
- Status
- Terminated
- Initiated
- 2021-04-16
- Posted
- not on file
- Terminated
- 2024-04-02
- Reason
- Elevated rates of false positive/false negative and control failures while using the Pneumonia Panel, due to issues identified in the manufacturing process.
- Root cause
- Under Investigation by firm
- Action
- 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.
- Quantity
- 9 kits (U.S. only)
- Distribution
- U.S. Nationwide distribution in the states of MN and OK. O.U.S.: None
- Lot, serial or model codes
- Part Number:RFIT-ASY-0144 UDI: 00815381020178 Kit Lot#: 0938121 Pouch Lot#: 19T621
- 510(k) numbers
- K180966
- PMA numbers
- not on file
- Product code
- QBH
- Firm FEI
- 3002773840
- Firm city
- Salt Lake City
- Firm state
- UT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28