Randox G-6-PDH Normal Control Recalled for Incorrect Target Values
Randox Laboratories is recalling 10 kits of G-6-PDH Normal 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, and the source text identifies a labeling/accuracy error (incorrect target values) without reporting any illnesses or injuries, fitting the criteria for a moderate severity score.
Plain-English summary
Randox Laboratories Ltd. is recalling 10 kits of G-6-PDH Normal Control (G-6-PDH CONTROL N), Catalogue Number PD2618. This product is intended for in vitro diagnostic use in the quality control of Glucose-6-Phosphate Dehydrogenase in erythrocytes.
The recall is being conducted because the target values and ranges in the affected lots are incorrect. The specific lot numbers involved are 676PD, 701PD, and 716PD.
The products were distributed to the following US states: Illinois, Ohio, North Carolina, Pennsylvania, Wisconsin, West Virginia, and Puerto Rico. Users of this product should stop using the affected lots and contact Randox Laboratories for further instructions.
The recalled product
- Product
- G-6-PDH Normal Control (G-6-PDH CONTROL N), Catalogue Number PD2618 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
- 10
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: 676PD 701PD 716PD
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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