Z-1786-2024Class III

Evidence MultiSTAT with software v 3.7-Analyzer intended for the qualitative determination of parent drug...

Name: Z-1786-2024 Evidence MultiSTAT with software v 3.7-Analyzer intended for the qualitative determination of parent drug...
Creator: Randox Laboratories Ltd.
Published: 2024-04-05
License: https://open.fda.gov/license/

Randox Laboratories, Limited / initiated 2024-04-05 / Open, Classified / root cause: design

FDA source

Randox Laboratories Ltd. began a recall of Evidence MultiSTAT with software v 3.7-Analyzer intended for the qualitative determination of parent drug molecule and metabolites of drugs in human urine... on 2024-04-05. FDA classified it as Class III and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-1786-2024
Classification: Class III
Status: Open, Classified
Initiated: 2024-04-05
Posted: 2024-05-09
Recalling firm: Randox Laboratories, Limited
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
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
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.
Root cause tag: design
FDA 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 [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
Quantity in commerce: 40 units
Distribution: US Nationwide distribution.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1786-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1786-2024	Class III	Ongoing	Voluntary: Firm initiated	2024-05-15	2024-05-09

Product code JJE

K220451Class IIEvidence MultiSTAT DOA Urine MultiPlex, Evidence MultiSTATRandox Laboratories Limited / cleared 2023-10-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)