Reported Sep 18, 2019 · Terminated
This is an in vitro diagnostic product intended for use as a calibration serum in clinical chemistry assays. Randox…
Randox Laboratories Ltd.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Randox Laboratories Ltd. · 55 Diamond Road · Crumlin (North) · N/A
Is this the product you have?
- 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.
- Lot codes and dates
- Lot Numbers961UE
- onwards GTN05055273200966
- Amount recalled
- 307 kits
Where it was sold
- Nationwide
Why it was 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).
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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