Recall Z-1911-2016 ยท LHJ Staphylococcus Aureus Protein A Insoluble
Integrated Science Systems Inc
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
| Date | Jun 3, 2016 (initiated Feb 19, 2016) |
| Status | Terminated |
| Reason | Customer complaints of very weak reactions with the kit, or false negative results with different Staph aureus cultures. |
| Root cause | Process control |
| Action | Integrated Science Systems sent a Recall Notification letter dated March 29, 2016. Integrated Science Systems requested that unopened kits in inventory be returned. Once the root cause has been determined, the kits will be reworked and returned to INOVA for distribution. For questions call 706-922-8686. |
| Quantity | 2625 kits |
| Distribution | Nationwide distribution to CA only. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.