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.
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 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.
See all 3 products in this recall →Related recalls
Same manufacturer · Randox Laboratories Ltd.
See all →- ModerateCystatin C Diagnostic Reagent Marketed Without FDA 510(k) Clearance
FDA (Devices) · 2024-07-31
- HighRandox Clinical Chemistry Calibration Serum Recalled for Measurement Bias
FDA (Devices) · 2024-05-15
- ModerateEvidence MultiSTAT analyzer foam gasket malfunction may affect test accuracy
FDA (Devices) · 2024-05-15
- HighMicroalbumin Calibrator Series Recall Due to Measurement Accuracy Issue
FDA (Devices) · 2024-04-24
- HighMicroalbumin Calibrator Series Recalled for Negative Bias and Patient Result Misclassification
FDA (Devices) · 2024-04-24
Same hazard · mis labeling
See all →- ModerateMedline Trach Tube Kit Recalled for Component Labeling Discrepancy
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02
- HighSura Tanmen Ramen Noodles Recalled for Undeclared Fish Allergens
FDA (Food) · 2026-09-02
- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-09-02