Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Calibration Serum Level 3 - IVD For use as a Recalled by Randox Laboratories Ltd. Due to Target for Alkaline Phosphatase (ALP) for the AMP...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Randox Laboratories Ltd. directly.
Affected Products
Calibration Serum Level 3 - IVD For use as a Calibrator in clinical chemistry assays Catalog Number: CAL2351
Quantity: 108 kits
Why Was This Recalled?
Target for Alkaline Phosphatase (ALP) for the AMP optimized to IFCC 37¿C method has been mis-assigned for the RX Series instruments by approximately 10% on Quality Control and patient samples
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Randox Laboratories Ltd.
Randox Laboratories Ltd. has 72 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report