Z-1448-2020Class III

FilmArray NGDS Warrior Panel, Ref: NGDS-ASY-0007, UDI: (01)00851458005136, IVD, Rx Only

Name: Z-1448-2020 FilmArray NGDS Warrior Panel, Ref: NGDS-ASY-0007, UDI: (01)00851458005136, IVD, Rx Only
Creator: Biofire Defense
Published: 2019-08-20
License: https://open.fda.gov/license/

BioFire Defense, LLC / initiated 2019-08-20 / Terminated / root cause: labeling and UDI

FDA source

Biofire Defense began a recall of FilmArray NGDS Warrior Panel, Ref: NGDS-ASY-0007, UDI: (01)00851458005136, IVD, Rx Only on 2019-08-20. FDA classified it as Class III and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1448-2020
Classification: Class III
Status: Terminated
Initiated: 2019-08-20
Posted: 2020-02-18
Terminated: 2020-10-30
Recalling firm: BioFire Defense, LLC
Product: FilmArray NGDS Warrior Panel, Ref: NGDS-ASY-0007, UDI: (01)00851458005136, IVD, Rx Only
Product code: PRD
Reason for recall: 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 tag: labeling and UDI
FDA 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 [email protected] or via telephone at 1-801-262-3592 for product technical support.
Quantity in commerce: 92 kits
Distribution: US: UT, MD, GA, CO, OH, TX, OUS: None
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1448-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1448-2020	Class III	Terminated	Voluntary: Firm initiated	2020-03-11	2020-03-05

Product code PRD

K170883FilmArray NGDS Warrior PanelBiofire Defense, LLC / cleared 2017-06-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)