FDA Device recall Z-2071-2020
The Optilite Clinical Chemistry Analyzer
- FDA Device
- Class II
- terminated
- Published 2020-05-27
On 2020-05-27 the FDA classified a Class II recall of The Optilite Clinical Chemistry Analyzer by The Binding Site Group, citing A software issue that may affect the analyzer's result accuracy.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2071-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-04-09 |
| Published | 2020-05-27 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | The Binding Site Group |
| Distribution | US |
Product
The Optilite Clinical Chemistry Analyzer. IVD. Model Number: IE700. UDI-05051700017176 - Product Usage: The Optilite 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.
Reason
A software issue that may affect the analyzer's result accuracy.
Identifiers
| code_info | Analyzers running with software version 7.0 or 7.01 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2071-2020%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.