Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
This is an in vitro diagnostic product intended for use Recalled by Randox Laboratories Ltd. Due to Randox Laboratories realigned RX Analyser Series calibration targets...
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
This is an in vitro diagnostic product intended for use as a calibration serum in clinical chemistry assays. Randox calibration sera contain 42 analytes and are based on lyophilized human serum. The concentrations and activities are suitable for calibration of clinical chemistry assays both manually and on a wide range of automatic analyzers. Constituent concentrations are available at 2 levels.
Quantity: 307 kits
Why Was This Recalled?
Randox Laboratories realigned RX Analyser Series calibration targets by 10% for AST and 9% for ALT in line with the Mean of All Instrument method target for the Randox Calibration Serum Level 3 (for calibrator lot 961UE onwards).
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