Randox G-6-PDH Deficient Control Recalled for Incorrect Target Values
Randox Laboratories is recalling 14 kits of G-6-PDH Deficient Control because the target values and ranges in specific lots are incorrect.
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 does not report any hospitalizations, injuries, or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Randox Laboratories Ltd. is recalling 14 kits of G-6-PDH Deficient Control (G-6-PDH CONTROL D), Catalogue Number PD2617. This product is intended for in vitro diagnostic use in the quality control of Glucose-6-Phosphate Dehydrogenase in erythrocytes.
The recall is due to incorrect target values and ranges in the affected lots. The specific lot numbers involved are 687PD, 700PD, and 715PD.
The products were distributed to the following US states: Illinois, Ohio, North Carolina, Pennsylvania, Wisconsin, West Virginia, and Puerto Rico. Users should stop using the product and contact the manufacturer for instructions.
The recalled product
- Product
- G-6-PDH Deficient Control (G-6-PDH CONTROL D), Catalogue Number PD2617 Product Usage: This product is intended for in vitro diagnostic use, in the quality control of Glucose-6-Phosphate Dehydrogenase in erythrocytes
- Manufacturer
- Randox Laboratories Ltd.
- Hazard
- Affected units
- 14
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)
- Lot Numbers: 687PD 700PD 715PD
Distribution
Part of a larger recall action
This product is one of 2 recalled by Randox Laboratories Ltd. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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