Recall Z-2071-2020— The Binding Site Group, Ltd.
Class II · Terminated
Class II FDA medical device recall by The Binding Site Group, Ltd., initiated 2020-04-09, terminated 2022-08-19. FDA's recall record names no specific 510(k) clearance for this event. 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..
- Recalling firm
- The Binding Site Group, Ltd.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-04-09
- Terminated
- 2022-08-19
- Firm location
- Birmingham, N/A, United Kingdom
Product description
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 for recall
A software issue that may affect the analyzer's result accuracy.
Data sourced from openFDA. This site is unofficial and independent of the FDA.