FDA Recalls Randox Liquid Protein Calibrators for Measurement Accuracy Error
Randox Laboratories recalled 166 units of Liquid Protein Calibrators (IT2691) after restandardization caused Ferritin results to read approximately 10% higher than targeted calibrator values.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II diagnostic device with systematic calibration inaccuracy affecting measurement results. The 10% error in Ferritin values represents a risk-of-harm to diagnostic accuracy, meeting the rubric criterion of risk-of-harm products where patient injury has not yet been reported.
Plain-English summary
Randox Laboratories Ltd. is recalling 166 units of Liquid Protein Calibrators (Catalogue Number IT2691). These in vitro diagnostic products are used to calibrate laboratory assays that measure multiple analytes including Ferritin, Complement C3 and C4, C-reactive protein (CRP), Haptoglobin, Immunoglobulin M, Prealbumin, Rheumatoid Factor, and Transferrin.
The recall stems from a restandardization of the Ferritin component of these calibrators using reference material NISBC 19/118. Following this restandardization, Ferritin measurement results from affected calibrator lots were approximately 10% higher than the intended target values across the full assay range.
The affected calibrator batches are 627222, 627224, 634886, and 634887, all with expiration date 28 July 2024. These products were distributed to clinical laboratories in California, Florida, Illinois, Maine, Michigan, North Carolina, Ohio, Pennsylvania, and New Jersey.
Laboratories currently using affected batches should contact Randox Laboratories for replacement materials. Ferritin results produced using these calibrators—for both quality control materials and patient samples—may be systematically elevated.
The recalled product
- Product
- Randox Liquid Protein Calibrators-SP CAL-(LIQ)-In vitro diagnostic product used for the calibration of ASO, Complement C3, Complement C4, CRP, Ferritin, Haptoglobin, IgM, Prealbumin, RF and Transferrin assays Catalogue Number: IT2691
- Manufacturer
- Randox Laboratories Ltd.
- Hazard
- calibration-inaccuracy
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 (6)
- GTIN: 05055273204032 Batch/ Lot number Expiry Date 590858 28 08 23
- 590859 28 08 23
- 627222 28Jul 24
- 627224 28Jul24
- 634886 28Jul24
- 634887 28Jul24
Distribution
Distributed in 9 states:
- CA
- FL
- IL
- ME
- MI
- NC
- NJ
- OH
- PA
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