Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
SP CAL (LIQ) Recalled by Randox Laboratories Ltd. Due to Calibrator value sheets have been modified for assigned...
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
SP CAL (LIQ), REF IT2692 This product is intended for in vitro diagnostic use with Randox Alpha-1-Antitrypsin, Alpha-1-Acid Glycoprotein, IgA, IgG and IgM assays that require sample predilution.
Quantity: 250 kits (32 kits US / 218 kits OUS)
Why Was This Recalled?
Calibrator value sheets have been modified for assigned value of Alpha-1-Acid-Glycoprotein (AGP), IgA and IgG to improve the alignment. IgG measurement reference has also been corrected.
Where Was This Sold?
This product was distributed to 5 states: IN, NJ, NY, TX, WV
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