CLASS III Device recall · Reported 11 Mar 2020 · FDA Enforcement Report
FilmArray NGDS Warrior Panel recalled by Biofire Defense
Biofire Defense is recalling FilmArray NGDS Warrior Panel, distributed in Colorado, Georgia, Maryland, Ohio, Texas, Utah. The recall was initiated on 20 Aug 2019 and the FDA has classified it as Class III.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1448-2020
- FDA event ID
- 84887
- Recalling firm
- Biofire Defense, Salt Lake City, UT
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 20 Aug 2019
- FDA classified
- 5 Mar 2020
- Reported
- 11 Mar 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 20 Aug 2019 | Recall initiated by company | |
| 5 Mar 2020 | Classified by FDA | +198 days |
| 11 Mar 2020 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
FilmArray NGDS Warrior Panel, Ref: NGDS-ASY-0007, UDI: (01)00851458005136, IVD, Rx Only
Where it was distributed
US: UT, MD, GA, CO, OH, TX, OUS: None
Questions about this recall
Why was it 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.
Which lots are affected?
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
Where was it sold?
US: UT, MD, GA, CO, OH, TX, OUS: None
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Biofire Defense
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | FilmArray NGDS Warrior Panel recalled by Biofire Defense | Biofire Defense | Device Malfunction | Nationwide |
| Device | CLASS II | FilmArray Ngds Warrior Panel Ngds-asy-0007 is a qualitative recalled | Biofire Defense | Device Malfunction | Nationwide |
| Device | CLASS III | Jbaids Instrument System recalled by Biofire Defense | Biofire Defense | Device Malfunction | Nationwide |
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