Recall Z-2071-2020 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
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.
| Date | Apr 9, 2020 |
| Status | Terminated |
| Reason | A software issue that may affect the analyzer's result accuracy. |
| Root cause | Software design |
| 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. |
| Quantity | 36 |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.