FilmArray NGDS Warrior Panel, Ref: NGDS-ASY-0007, UDI:… recallZ-1448-2020 · Biofire Defense · initiated Aug 20, 2019
Class III Terminated All recalls posted in February 2020
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Biofire Defense or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Labeling Change Control
What the company is doing
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 [email protected] or via telephone at 1-801-262-3592 for product technical support.
Recall details
- Recall number
- Z-1448-2020
- Recall class
- Class III
- Status
- Terminated
- Initiated by the company
- Aug 20, 2019
- Posted by the FDA
- Feb 18, 2020
- Recalling firm
- Biofire Defense
- Quantity
- 92 kits
- Product code
- PRD
- FDA submissions
- K170883
- Distribution
- US: UT, MD, GA, CO, OH, TX, OUS: None
Product description
FilmArray NGDS Warrior Panel, Ref: NGDS-ASY-0007, UDI: (01)00851458005136, IVD, Rx Only
Code information (models, lots, serial numbers)
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
Other devices under the same FDA submission
1 device cleared under K170883 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- FilmArray® NGDS Warrior Panel NGDS-ASY-0007Biofire Defense, LLC · Biothreat Microbial Agents Multiplex Nucleic Acid Detection System2 recalls0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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