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
- Recall Number
- Z-2071-2020
- Event Number
- 85492
- Firm
- The Binding Site Group, Ltd.
- FEI Number
- 3002808340
- Product Code
- JJE
- Status
- Terminated
- Root Cause
- Software design
- Initiated
- April 9, 2020
- Terminated
- August 19, 2022
- Address
- 8 Calthorpe Road, Birmingham United Kingdom
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.
A software issue that may affect the analyzer's result accuracy.
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.
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.
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