Randox SP CAL (LIQ) Calibrator Recall for Value Sheet Corrections
Randox Laboratories is recalling SP CAL (LIQ) calibrators because value sheets were modified to improve alignment for specific assays.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text describes a correction to value sheets and references to improve alignment, which aligns with the rubric for minor labeling errors or voluntary precautionary recalls without reported injuries.
Plain-English summary
Randox Laboratories Ltd. is recalling 250 kits of SP CAL (LIQ), Reference 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.
The recall was initiated because the calibrator value sheets have been modified for the assigned values of Alpha-1-Acid-Glycoprotein (AGP), IgA, and IgG to improve alignment. Additionally, the IgG measurement reference has been corrected. The affected lot number is 415879, with an expiry date of 28 March 2019.
The product was distributed in the United States to the states of Indiana, New Jersey, New York, Texas, and West Virginia, as well as internationally to Ireland. Users of this product should stop using the affected kits and contact Randox Laboratories for further instructions.
The recalled product
- Product
- 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.
- Manufacturer
- Randox Laboratories Ltd.
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- 05055273204049 Lot Number: 415879 Date of Expiry - 28 March 2019
Distribution
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