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.
This recall has been terminated (originally issued April 9, 2020).
- Company
- The Binding Site Group, Ltd.
- Recall Initiated
- April 9, 2020
- Terminated
- August 19, 2022
- Recall Number
- Z-2071-2020
- Quantity
- 36
- Firm Location
- Birmingham United Kingdom
- Official Source
- View on FDA website ↗
Reason for Recall
A software issue that may affect the analyzer's result accuracy.
Distribution
US Nationwide distribution including in the states of AL, AR, CA, FL, IL, IN, KS, KY, MA, MN, NC, NE, OH, PA, TX and VA.
Lot / Code Info
Analyzers running with software version 7.0 or 7.01
Root Cause
Software design
Action Taken
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.