Randox Laboratories Ltd. Recall 94371
Description: 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
Randox Laboratories Ltd. Recall 94371 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1786-2024 |
| Event ID | 94371 |
| Event Description | 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 |
| Product Type | Devices |
| Distribution | US Nationwide distribution. |
| Quantity | 40 units |
| Recall 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. |
| Device Classification | 20240515 |
| Device Code Info | GTIN: 05055273214970 Serial Numbers: 052-23-0424 052-23-0425 052-23-0434 052-23-0437 052-23-0618 052-23-0611 052-23-0516 052-23-0522 052-23-0490 052-23-0491 052-23-0439 052-23-0440 052-23-0441 052-23-0445 052-23-0449 052-23-0450 052-23-0451 052-23-0452 052-23-0438 052-22-0276 052-22-0277 052-22-0279 052-23-0416 052-22-0283 052-22-0271 052-21-0260 052-21-0255 052-21-0249 052-23-0418 052-23-0419 052-23-0415 052-23-0417 052-22-0268 052-23-0420 052-22-0284 052-23-0448 052-23-0444 052-23-0443 052-23-0442 052-23-0609 |
| Center Classification Date | 20240509 |
| Recall Initiation Date | 20240405 |
| Recalling Firm | Randox Laboratories Ltd. |
| Initial Notification | |
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