Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland 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 Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
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
Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland is recalling Evidence MultiSTAT with software v 3.7-Analyzer intended for the qualitative determination of parent due to 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 le. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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 Safety Notice: Send a copy of the FSN to all affected customers and to those who need to be aware within your organisation
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026