Randox SP CAL (LIQ) Calibrator Recall for Value Sheet Corrections
Randox Laboratories is recalling SP CAL (LIQ) calibrators because value sheets were modified to improve alignment for specific assays.
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, but the source text describes a correction to value sheets and references to improve alignment, which aligns with the rubric for minor labeling errors or voluntary precautionary recalls without reported injuries.
Plain-English summary
Randox Laboratories Ltd. is recalling 250 kits of SP CAL (LIQ), Reference IT2692. This product is intended for in vitro diagnostic use with Randox Alpha-1-Antitrypsin, Alpha-1-Acid Glycoprotein, IgA, IgG, and IgM assays that require sample predilution.
The recall was initiated because the calibrator value sheets have been modified for the assigned values of Alpha-1-Acid-Glycoprotein (AGP), IgA, and IgG to improve alignment. Additionally, the IgG measurement reference has been corrected. The affected lot number is 415879, with an expiry date of 28 March 2019.
The product was distributed in the United States to the states of Indiana, New Jersey, New York, Texas, and West Virginia, as well as internationally to Ireland. Users of this product should stop using the affected kits and contact Randox Laboratories for further instructions.
The recalled product
- Product
- SP CAL (LIQ), REF IT2692 This product is intended for in vitro diagnostic use with Randox Alpha-1-Antitrypsin, Alpha-1-Acid Glycoprotein, IgA, IgG and IgM assays that require sample predilution.
- Manufacturer
- Randox Laboratories Ltd.
- Hazard
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)
- 05055273204049 Lot Number: 415879 Date of Expiry - 28 March 2019
Distribution
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 Recalled for Negative Bias and Patient Result Misclassification
FDA (Devices) · 2024-04-24
- HighMicroalbumin Calibrator Series Recall Due to Measurement Accuracy Issue
FDA (Devices) · 2024-04-24
Same hazard · mis labeling
See all →- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-10-14
- SevereBetter Bakehouse Recalls Donutful Chocolate Dipped Vanilla Cake Donuts for Undeclared Milk
FDA (Food) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- ModerateHalyard Laparoscopy Comprehensive Pack II Recalled for Latex Content
FDA (Devices) · 2026-10-14
Similar recalls
- ModerateRandox Liquid Protein Calibrators Recalled for Rheumatoid Factor Value Adjustment
FDA (Devices) · 2019-11-13
- HighFDA Recalls Randox Liquid Protein Calibrators for Measurement Accuracy Error
FDA (Devices) · 2023-08-30
- ModerateLiquid Protein Calibrators recalled for reference material realignment correction
FDA (Devices) · 2024-03-27
- ModerateRandox IgE Calibrator Series Recall for Value Alignment
FDA (Devices) · 2016-10-12
- ModerateSoluble Transferrin Receptor Calibrator Recall Due to Lab Errors
FDA (Devices) · 2022-07-27
- ModerateRandox Fructosamine Control 3 Calibrator Recall Due to Value Reassignment
FDA (Devices) · 2019-03-27