Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Calibration Serum Level 3 CAL2351 Recalled by Randox Laboratories Ltd. Due to CK Total in Calibration Serum Level 3, CAL2351,...
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 CAL2351
Quantity: 269 kits
Why Was This Recalled?
CK Total in Calibration Serum Level 3, CAL2351, is running with a positive bias on RX Series instruments compared to other methods experience a shift in Quality Control and patient sample recovery of up to 13%.
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