Randox Liquid Protein Calibrators-SP CAL-(LIQ)-In vitro diagnostic product used for the… Recall
Issued August 30, 2023 · Randox Laboratories Ltd.
In August 2023, Randox Laboratories Ltd. recalled the Randox Liquid Protein Calibrators-SP CAL-(LIQ)-In vitro diagnostic product used for the…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
As part of the firm's ongoing quality monitoring (see internal complaint # OCC72574), Randox Laboratories have restandardized Ferritin in Liquid Protein Calibrators, IT2691, to reference material NISBC 19/118. The calibrators lots 2112IT-2116IT, packed into batches 627222, 627224, 634886 and 634887 have been reassigned as part of the restandardization. Following this restandardization, Ferritin results for Quality Control material and patient samples recovered erroneously higher than the targeted calibrator values by approximately +10% across the assay range following.
What you should do
- 1 Stop using Randox Liquid Protein Calibrators-SP CAL-(LIQ)-In vitro diagnostic product used for the… 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.
Recall details
- Brand
- Randox Laboratories Ltd.
- Category
- Health
- Recall date
- August 30, 2023
- Units affected
- Not reported
- Sold at
- CA, FL, IL, ME, MI, NC, OH, PA,NJ,
- Recall number
- FDA-Z-2448-2023
- 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.