The Binding Site Group, Ltd. 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
The Binding Site Group, Ltd.
Lot Codes / Batch Numbers
Analyzers running with software version 7.0 or 7.01
Products Sold
Analyzers running with software version 7.0 or 7.01
The Binding Site Group, Ltd. is recalling The Optilite Clinical Chemistry Analyzer. IVD. Model Number: IE700. UDI-05051700017176 - Product Usa due to A software issue that may affect the analyzer's result accuracy.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
A software issue that may affect the analyzer's result accuracy.
Recommended Action
Per FDA guidance
The field safety notice has been issued from The Binding Site UK office to The Binding Site US office. The Binding Site US office will notify affected end users in the US. An e-back form will be provided to affected customers along with the FSN. The FSN requests the customer to complete, sign and return the e-back form to The Binding Site to confirm that they have received and understood the FSN.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026