Optilite Analyser — Class II medical device recall Z-1018-2017
Terminated recall by The Binding Site Group, Ltd., reported 2017-01-25, distributed nationwide. Potential risk of the Optilite lid/cover falling suddenly and causing injury when not placed in the fully open
| Recall number | Z-1018-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | The Binding Site Group, Ltd., Birmingham, United Kingdom |
| Recall initiated | 2015-05-13 |
| Classified | 2017-01-13 |
| Reported by FDA | 2017-01-25 |
| Terminated | 2017-01-17 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BE, CA, CN, CZ, DE, ES, FR, GB, IE, IL, IT, PT |
| Quantity | 129 units |
| UPC / GTIN / UDI-DI | 00864000290447, 00864000290836, 00864000290850 |
Product
Optilite Analyser, Product Code: IE700 Product Usage: The Thermo Scientific Indiko Clinical Chemistry Analyzer is a fully automated random access analyzer used to measure a variety of analytes that may be adaptable to the analyzer depending on the reagent used. The Indiko Glucose (H-K) test system, is intended for in vitro diagnostic use in the quantitative determination of the glucose concentration in human plasma on the Indiko analyzer. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemnia, and of pancreatic islet cell carcinoma.
Reason for recall
Potential risk of the Optilite lid/cover falling suddenly and causing injury when not placed in the fully open position.
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-1018-2017. 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.