Reported Mar 11, 2020 · Terminated
FilmArray NGDS Warrior Panel, Ref: NGDS-ASY-0007, UDI: (01)00851458005136, IVD, Rx Only
Biofire Defense
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Biofire Defense · 79 W 4500 S · Salt Lake City, UT · 84107-2649
Is this the product you have?
- FilmArray NGDS Warrior Panel
- RefNGDS-ASY-0007
- UDI(01)00851458005136, IVD, Rx Only
- Lot codes and dates
- Lot No./Expiration Date
457117D/2018-10-17416118D/2019-03-15439218D/2019-06-12439318D/2019-07-18454218D/2019-08-21454318D/2019-08-22455518D/2019-08-23458118D/2019-09-18458218D/2019-09-19458018D/2019-09-20464018D/2019-10-02425719D/2020-05-30462819D/2020-06-10
- Lot No./Expiration Date
- Amount recalled
- 92 kits
Where it was sold
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.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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