Randox Laboratories Ltd. 2023-07-05 Health moderate FDA
Health · FDA · Recall #FDA-Z-2021-2023
Immunoassay Premium Level 3-In vitro diagnostic use, as assayed quality control material… Recall
Issued July 5, 2023 · Randox Laboratories Ltd.
In July 2023, Randox Laboratories Ltd. recalled the Immunoassay Premium Level 3-In vitro diagnostic use, as assayed quality control material…, a moderate health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Delay in reporting results due to Quality Controls running high outside of range. Target value and range for ACTH in Immunoassay Premium Level 3, IA2640, lot 2031EC and Immunoassay Premium Control Tri Level kit batch 583135 lot 2031EC has been reassigned on the Roche Cobas e801 due to High recovery outside range
What you should do
- 1 Stop using Immunoassay Premium Level 3-In vitro diagnostic use, as assayed quality control material… 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
- July 5, 2023
- Units affected
- Not reported
- Sold at
- CA, IL, VA, WA, WI including PR
- Recall number
- FDA-Z-2021-2023
- 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.