Randox Laboratories Ltd. 2023-08-16 Health serious FDA
Health · FDA · Recall #FDA-Z-2362-2023
Randox RX Series Urea Enzymatic Kinetic Assay Ref. Numbers: (1) UR3825 (2) UR3873 … Recall
Issued August 16, 2023 · Randox Laboratories Ltd.
In August 2023, Randox Laboratories Ltd. recalled the Randox RX Series Urea Enzymatic Kinetic Assay Ref. Numbers: (1) UR3825 (2) UR3873 …, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Carryover from the Direct LDL-cholesterol assay on the Rx instruments may result in a negative bias, up to -11%, in quality control and patient samples, in urea assays results if the urea assay is run immediately after the Direct LDL-cholesterol assay. This may lead to a delay in reporting results or in falsely decreased urea test results.
What you should do
- 1 Stop using Randox RX Series Urea Enzymatic Kinetic Assay Ref. Numbers: (1) UR3825 (2) UR3873 … 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
- August 16, 2023
- Units affected
- Not reported
- Sold at
- US Nationwide distribution in the states of CA, DC, GA, OH, OK, MN, MO, NJ, VA and Puerto Rico.
- Recall number
- FDA-Z-2362-2023
- 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 903rd Health recall we've logged in 2023.