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.
FDA Recall Z-2071-2020 · Posted None
Recalling FirmThe Binding Site Group, Ltd.
Recall StatusTerminated
Product CodeJJE
Date Initiated2020-04-09
Date Terminated2022-08-19
Product Quantity36
Reason for Recall
A software issue that may affect the analyzer's result accuracy.
Firm Action
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.
Root Cause
Software design
Distribution Pattern
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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.