CLASS III ONGOING Device recall · Reported 15 May 2024 · FDA Enforcement Report
Evidence MultiSTAT recalled by Randox Laboratories
Randox Laboratories is recalling Evidence MultiSTAT, distributed nationwide in the US. The recall was initiated on 5 Apr 2024 and the FDA has classified it as Class III.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1786-2024
- FDA event ID
- 94371
- Recalling firm
- Randox Laboratories, Crumlin (North), N/A
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- 5 Apr 2024
- FDA classified
- 9 May 2024
- Reported
- 15 May 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Packaging Defects
- Device type
- Test Kits & Diagnostics
Timeline
| 5 Apr 2024 | Recall initiated by company | |
| 9 May 2024 | Classified by FDA | +34 days |
| 15 May 2024 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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
Where it was distributed
US Nationwide distribution.
Questions about this recall
Why was it 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.
Which lots are affected?
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
Where was it sold?
US Nationwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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