Official recall record
Evidence MultiSTAT with software v 3.7-Analyzer intended for the qualitative determination of parent drug molecule and metabolites of drugs
- Issuing authority
- US FDA — Medical Devices
- Alert date
- 2024-04-05
- Country of alert
- Ireland
- Alert level
- Class III
- Alert type
- recall
- Barcode (EAN/GTIN)
- 05055273214970
- Brand on record
- Randox Laboratories Ltd.
What the authority reported
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.
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.
Record last checked against the registry on 2026-05-31.
ProductGuru Recalls republishes official safety information with attribution. We are not
the issuing authority and this page is not advice. If this product is a medical device or
medication, speak to a doctor or pharmacist. Found an error?
Report it — corrections are published.