Randox IgE Calibrator Series Recall for Value Alignment
Randox Laboratories is recalling IgE Calibrator Series units to align value assignments with the 3rd International Standard for human serum IgE.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 technical alignment of calibrator values to an international standard without reporting any illnesses, injuries, or adverse health consequences, fitting the criteria for a moderate, precautionary recall.
Plain-English summary
Randox Laboratories Ltd. is recalling four units of the IgE Calibrator Series (Catalogue number IE2492, Batch numbers 354213 and 386994). The recall involves consignees located in the United States.
The firm states that the value assignment for the IgE Calibrator Series IE2492 (lot 387-392IE) has been aligned to the 3rd International Standard for human serum IgE 11/234. As a result, Turbidimetric (Non-IFCC Cal.) Quality Control Targets and Ranges now apply, and the calibrator value sheet is to be updated with the new values.
The source text does not specify instructions for consumers or end-users regarding the disposal or replacement of these specific units.
The recalled product
- Product
- IgE Calibrator Series
- Manufacturer
- Randox Laboratories Ltd.
- Hazard
- Affected units
- 4
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 (2)
- Catalogue number IE2492 Batch number 354213
- 386994
Distribution
Distribution scope not specified by the agency.
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