FilmArray NGDS Warrior Panel, Ref: NGDS-ASY-0007, UDI: (01)00851458005136, IVD, Rx Only
Reported: March 11, 2020 Initiated: August 20, 2019 #Z-1448-2020
Product Description
FilmArray NGDS Warrior Panel, Ref: NGDS-ASY-0007, UDI: (01)00851458005136, IVD, Rx Only
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.
Details
- Recalling Firm
- Biofire Defense
- Units Affected
- 92 kits
- Distribution
- US: UT, MD, GA, CO, OH, TX, OUS: None
- Location
- Salt Lake City, UT
Frequently Asked Questions
What product was recalled? ▼
FilmArray NGDS Warrior Panel, Ref: NGDS-ASY-0007, UDI: (01)00851458005136, IVD, Rx Only. Recalled by Biofire Defense. Units affected: 92 kits.
Why was this product 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 agency issued this recall? ▼
This recall was issued by the FDA Devices on March 11, 2020. Severity: Low. Recall number: Z-1448-2020.
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