Evidence MultiSTAT with software v 3 — Class III medical device recall Z-1786-2024
Ongoing recall by Randox Laboratories Ltd., reported 2024-05-15, distributed nationwide. Foam gasket on the Evidence MultiSTAT chip heater assembly may not perform as expected. Foam that is not funct
| Recall number | Z-1786-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Randox Laboratories Ltd., Crumlin (North), N/A, Ireland |
| Recall initiated | 2024-04-05 |
| Classified | 2024-05-09 |
| Reported by FDA | 2024-05-15 |
| Distributed | Nationwide (US) |
| Quantity | 40 units |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 05055273214970 |
| Serial numbers | 052-21-0249, 052-21-0255, 052-21-0260, 052-22-0268, 052-22-0271, 052-22-0276, 052-22-0277, 052-22-0279, 052-22-0283, 052-22-0284, 052-23-0415, 052-23-0416, 052-23-0417, 052-23-0418, 052-23-0419, 052-23-0420, 052-23-0424, 052-23-0425, 052-23-0434, 052-23-0437, 052-23-0438, 052-23-0439, 052-23-0440, 052-23-0441, 052-23-0442 and 15 more |
| Model numbers | EV4115 |
Product
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
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1786-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.