Recall Z-1786-2024 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Randox Laboratories Ltd.
Evidence MultiSTAT with software v 3.7-Analyzer intended for the qualitative determination of parent drug molecule and metabolites of drugs in human urine Catalog Number: EV4115
| Date | May 9, 2024 (initiated Apr 5, 2024) |
| Status | Open, Classified |
| Reason | Foam gasket on the Evidence MultiSTAT chip heater assembly may not perform as expected. Foam that is not functioning as expected may cause light to leak into the Charged Coupled Device (CCD) Camera during imaging. This will affect the testing and may delay in reporting results. |
| Root cause | Device Design |
| Action | Randox Laboratories Ltd UK notified the US Distributor Randox Laboratories via email on 4/05/ 24. End-Users notified by email on 4/9/24. Letter (REC736) states reason for recall, health risk and action to take: " Export support files for the last 10 samples run and share with Randox using the link to be provided " Discuss the contents of this notice with your Medical Director. " Complete and return the response form 12187-QA to technical.services@randox.com within five working days. " Affected chip heater assembly replacement to be arranged by Randox Service Engineer Transmission of Field Saf |
| Quantity | 40 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K220451 | Evidence MultiSTAT DOA Urine MultiPlex, Evidence MultiSTAT Randox Laboratories Limited, Oct 5, 2023 |