Evidence MultiSTAT with software v 3.7-Analyzer intended… recallZ-1786-2024 · Randox Laboratories Ltd. · initiated Apr 5, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Randox Laboratories Ltd. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Device Design
What the company is doing
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 [email protected] within five working days. " Affected chip heater assembly replacement to be arranged by Randox Service Engineer Transmission of Field Safety Notice: Send a copy of the FSN to all affected customers and to those who need to be aware within your organisation
Recall details
- Recall number
- Z-1786-2024
- Status
- Open, Classified
- Initiated by the company
- Apr 5, 2024
- Posted by the FDA
- May 9, 2024
- Recalling firm
- Randox Laboratories Ltd.
- Quantity
- 40 units
- Product code
- JJE
- FDA submissions
- K220451
- Distribution
- US Nationwide distribution.
Product 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
Code information (models, lots, serial numbers)
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
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Evidence MultiSTAT EV4115Randox Laboratories Limited · Analyzer, Chemistry (Photometric, Discrete), For Clinical Use1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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