Recall Z-1448-2020— Biofire Defense
Class III · Terminated
Class III FDA medical device recall by Biofire Defense, initiated 2019-08-20, terminated 2020-10-30. It names one FDA 510(k) clearance: K170883. Product: FilmArray NGDS Warrior Panel, Ref: NGDS-ASY-0007, UDI: (01)00851458005136, IVD, Rx Only. 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..
- Recalling firm
- Biofire Defense
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2019-08-20
- Terminated
- 2020-10-30
- Firm location
- Salt Lake City, UT, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.