Reported May 15, 2024 · Ongoing
Evidence MultiSTAT with software v 3.7-Analyzer intended for the qualitative determination of parent drug molecule and…
Randox Laboratories Ltd.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Randox Laboratories Ltd. · 55 Diamond Road · Crumlin (North), N/A · N/A
Is this the product you have?
- 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 NumberEV4115
- Lot codes and dates
- GTIN05055273214970
- Serial Numbers
052-23-0424052-23-0425052-23-0434052-23-0437052-23-0618052-23-0611052-23-0516052-23-0522052-23-0490052-23-0491052-23-0439052-23-0440052-23-0441052-23-0445052-23-0449052-23-0450052-23-0451052-23-0452052-23-0438052-22-0276052-22-0277052-22-0279052-23-0416052-22-0283052-22-0271052-21-0260052-21-0255052-21-0249052-23-0418052-23-0419052-23-0415052-23-0417052-22-0268052-23-0420052-22-0284052-23-0448052-23-0444052-23-0443052-23-0442052-23-0609
- Amount recalled
- 40 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
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.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Randox Laboratories Ltd. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.