Sure Vue Color Staph 150T — Class II medical device recall Z-1911-2016
Terminated recall by Integrated Science Systems Inc, reported 2016-06-15, distributed nationwide. Customer complaints of very weak reactions with the kit, or false negative results with different Staph aureus
| Recall number | Z-1911-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Integrated Science Systems Inc, Augusta, GA, United States |
| Recall initiated | 2016-02-19 |
| Classified | 2016-06-03 |
| Reported by FDA | 2016-06-15 |
| Terminated | 2017-02-28 |
| Distributed | Nationwide (US) |
| Quantity | 2,625 kits |
| Lot numbers | J06022, KJ05016, KJ05017, KJ05018, KJ06019, KJ06020, KJ06021, KJ07023, KJ07024, KJ07025, KJ09026, KJ09027, KJ10028, KJ10029, KJ10030, KJ11034, KJ11035, KJ12040, KJ12041, KJ12042, KJ12043 |
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
Reason for recall
Customer complaints of very weak reactions with the kit, or false negative results with different Staph aureus cultures.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1911-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.