Z-1911-2016 Class II Terminated
FDA device recall Z-1911-2016 was initiated by Integrated Science Systems Inc on February 19, 2016 and is designated Class II. Reason for recall: Customer complaints of very weak reactions with the kit, or false negative results with different Staph aureus cultures. The recall status is terminated (terminated February 28, 2017). Affected quantity: 2625 kits.
Recall Details
- Product Type
- Devices
- Report Date
- June 15, 2016
- Initiation Date
- February 19, 2016
- Termination Date
- February 28, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2625 kits
Product Description
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
Reason for Recall
Customer complaints of very weak reactions with the kit, or false negative results with different Staph aureus cultures.
Distribution Pattern
Nationwide distribution to CA only.
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