Randox Immunoassay Controls Recalled for Incorrect Analyzer Target Value
Randox Laboratories is recalling Immunoassay Premium Plus 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 is defined as unlikely to cause adverse health consequences. The issue is a documentation error regarding a target value, not a direct safety hazard.
Plain-English summary
Randox Laboratories Ltd. is recalling 12 units of Immunoassay Premium Plus Controls, Model Numbers IA3109 and IA3112. The product is intended for in vitro diagnostic use as assayed quality control material to monitor the accuracy and reproducibility of analytes.
The recall was initiated because the target value for uptake is incorrect on the value sheet for an analyzer. The target value is listed as 43.8%U but should be 39.4%U.
The affected products were distributed to West Virginia and Puerto Rico. The lot codes for the recalled items are 1714EC, 430312, and 432364. Users should stop using the affected lots and contact the manufacturer for instructions.
The recalled product
- Product
- Immunoassay Premium Plus Controls, Model Numbers IA3109 and IA3112 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
- 12
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: 1714EC 430312 432364
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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