FDA Medical Device Recalls (openFDA)
Biofire Defense: FilmArray NGDS Warrior Panel, Ref: NGDS-ASY-0007, UDI: (01)00851458005136, IVD, Rx Only
- Recall number
- Z-1448-2020
- Recalling firm
- Biofire Defense
- Product
- FilmArray NGDS Warrior Panel, Ref: NGDS-ASY-0007, UDI: (01)00851458005136, IVD, Rx Only
- Status
- Terminated
- Initiated
- 2019-08-20
- Posted
- 2020-02-18
- Terminated
- 2020-10-30
- Reason
- The firm has identified that an incorrect instruction for use (IFU) revision was included in the qualitative, multiplexed, nucleic acid-based in vitro diagnostic test kit.
- Root cause
- Labeling Change Control
- Action
- On 8/20/2019, a "Urgent: Customer Recall Notice" letter was sent to all affected consignees informing them on the recall. In addition to providing information on the recall, the firm asked consignees do the following: 1. BFDf has enclosed a replacement printed copy of the Revision 02 Warrior IFU with this notice. BFDf advises customers to remove and dispose of all incorrect IFUs included in non-expired product from the affected lots listed. BFDf will provide additional replacement copies of the IFU on request. 2. Please complete and return the accompanying Recall Acknowledgement of Receipt Form included with this Notice, using one of the listed methods to confirm your receipt of this notification. 3. If you have any additional questions or concerns, please do not hesitate to contact BFDf Customer Support via email at Support@biofiredefense.com or via telephone at 1-801-262-3592 for product technical support.
- Quantity
- 92 kits
- Distribution
- US: UT, MD, GA, CO, OH, TX, OUS: None
- Lot, serial or model codes
- Lot No./Expiration Date 457117D/2018-10-17 416118D/2019-03-15 439218D/2019-06-12 439318D/2019-07-18 454218D/2019-08-21 454318D/2019-08-22 455518D/2019-08-23 458118D/2019-09-18 458218D/2019-09-19 458018D/2019-09-20 464018D/2019-10-02 425719D/2020-05-30 462819D/2020-06-10
- 510(k) numbers
- ["K170883"]
- PMA numbers
- not on file
- Product code
- PRD
- Firm FEI
- 3010770794
- 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