FDA Device recall Z-1018-2017
Optilite Analyser, Product Code: IE700 Product Usage: The Thermo Scientific Indiko Clinical Chemistry Analyzer is a fully automated random…
- FDA Device
- Class II
- terminated
- Published 2017-01-25
On 2017-01-25 the FDA classified a Class II recall of Optilite Analyser, Product Code: IE700 Product Usage: The Thermo Scientific Indiko Clinical Chemistry Analyzer is a fully automated random… by The Binding Site Group, citing potential risk of the Optilite lid/cover falling suddenly and causing injury when not placed in the fully open position.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1018-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-05-13 |
| Published | 2017-01-25 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | The Binding Site Group |
| Distribution | US |
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
Potential risk of the Optilite lid/cover falling suddenly and causing injury when not placed in the fully open position.
Identifiers
| code_info | 864000290243 864000290832 864000290244 864000290833 864000290330 864000290834 864000290447 864000290836 864…864000290243 864000290832 864000290244 864000290833 864000290330 864000290834 864000290447 864000290836 864000290448 864000290837 864000290449 864000290838 864000290452 864000290844 864000290826 864000290845 864000290827 864000290846 864000290828 864000290847 864000290831 864000290850 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1018-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.