Randox Immunoassay Premium Controls Recalled for Incorrect Analyzer Target Values
Randox Laboratories is recalling 58 units of Immunoassay Premium Controls due to an incorrect target value listed on the analyzer value sheet.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which indicates the product is not likely to cause adverse health consequences. The issue is a documentation error regarding target values rather than a direct safety hazard.
Plain-English summary
Randox Laboratories Ltd. is recalling 58 units of Immunoassay Premium Controls, Model Numbers IA2633 and IA2638. The recall is due to an error in the target value for uptake listed on the value sheet for an analyzer. The sheet incorrectly lists the value as 43.8%U, whereas the correct value is 39.4%U.
The affected products were distributed to West Virginia and Puerto Rico. The specific lot codes involved are 440941 and 1720EC. These products are intended for in vitro diagnostic use as assayed quality control material to monitor the accuracy and reproducibility of analytes.
Users of these products should stop using the affected lots and contact Randox Laboratories for further instructions or a replacement.
The recalled product
- Product
- Immunoassay Premium Controls, Model Numbers IA2633 and IA2638 Product Usage: This product is intended for in vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of analytes listed in the package insert
- Manufacturer
- Randox Laboratories Ltd.
- Hazard
- Affected units
- 58
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 codes: 440941 1720EC
Distribution
Part of a larger recall action
This product is one of 3 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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