Device product
Sure Vue Color Staph 150T, Sure Vue Color Staph 300T, Sure Vue SELECT Staph, biokit SELECT Staph 75T The product is used as an aid in the identification of Staphylococcus aureus from Culture
Z-1911-2016
Product summary
- Event
- Event 74140
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2625 kits
- Official record key
device-enforcement:Z-1911-2016
Official wording
Reason: Customer complaints of very weak reactions with the kit, or false negative results with different Staph aureus cultures.
Code information: Lot Numbers - KJ05016, KJ05017, KJ05018, KJ06019, KJ06020, KJ06021, KJ07023, KJ10028, J06022, KJ07024, KJ07025, KJ09026, KJ09027, KJ10029, KJ10030, KJ11034, KJ11035, KJ12040, KJ12041, KJ12042, KJ12043
Distribution pattern: Nationwide distribution to CA only.
Derived failure modes
-
Unknown
Customer complaints of very weak reactions with the kit, or false negative results with different Staph aureus cultures.