Randox Laboratories Ltd. 2024-05-15 Health moderate FDA
Health · FDA · Recall #FDA-Z-1786-2024
Evidence MultiSTAT with software v 3.7-Analyzer intended for the qualitative… Recall
Issued May 15, 2024 · Randox Laboratories Ltd.
In May 2024, Randox Laboratories Ltd. recalled the Evidence MultiSTAT with software v 3.7-Analyzer intended for the qualitative…, a moderate health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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 you should do
- 1 Stop using Evidence MultiSTAT with software v 3.7-Analyzer intended for the qualitative… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Randox Laboratories Ltd. to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Randox Laboratories Ltd.
- Category
- Health
- Recall date
- May 15, 2024
- Units affected
- Not reported
- Sold at
- US Nationwide distribution.
- Recall number
- FDA-Z-1786-2024
- Made in
- Ireland
- Issuing agency
- FDA
In context
- Randox Laboratories Ltd. has 5 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 737th Health recall we've logged in 2024.