Randox Liquid Immunoassay Premium Controls Recalled for Incorrect Target Value
Randox Laboratories is recalling Liquid Immunoassay Premium Controls because the target value for uptake is incorrect on the value sheet.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
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 by definition is unlikely to cause adverse health consequences. The issue is a documentation error regarding a target value, with no reported injuries or illnesses.
Plain-English summary
Randox Laboratories Ltd. is recalling four units of Liquid Immunoassay Premium Controls, Model Number LIA3105. 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 currently listed as 43.8%U, but it should be 39.4%U.
The affected products, identified by lot code 1723EC, were distributed to West Virginia and Puerto Rico. Users should stop using the product and contact the manufacturer for instructions.
The recalled product
- Product
- Liquid Immunoassay Premium Controls, Model Number LIA3105 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
- 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 (1)
- Lot codes: 1723EC
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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