Medical Diagnostic Calibration Serum Recalled for Positive Measurement Bias
Randox Laboratories is recalling Calibration Serum Level 3 (CAL2351) distributed in the US and Puerto Rico because it exhibits a positive bias in CK Total measurements on RX Series instruments, potentially affecting test accuracy by up to 13%.
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 3/5 (High).
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: This is an FDA Class II recall of a diagnostic calibration standard with a documented 13% positive bias affecting measurement accuracy. Although no illnesses have been reported, the product represents a risk of harm through potential diagnostic inaccuracy in clinical laboratory testing.
Plain-English summary
Randox Laboratories Ltd. is recalling 269 kits of Calibration Serum Level 3 (CAL2351) in affected lot numbers 1214UE, 1249UE, 1260UE, 1262UE, 1268UE, 1297UE, 1298UE, and 1315UE. The product was distributed nationwide in the US and Puerto Rico.
Calibration serum is a reference standard used in clinical laboratory testing of CK Total, a diagnostic marker. The recalled product exhibits a positive bias in CK Total measurements when used with RX Series instruments. This positive bias causes a shift of up to 13% in quality control and patient sample recovery compared to other measurement methods.
A positive bias in calibration standards means the product produces artificially elevated reference values. When inaccurate calibration standards are used, the resulting patient test values can be unreliable. This can affect the accuracy and reliability of diagnostic testing using the affected equipment.
Laboratories using affected lot numbers should contact Randox Laboratories Ltd. for replacement calibration serum.
The recalled product
- Product
- Calibration Serum Level 3 CAL2351
- Manufacturer
- Randox Laboratories Ltd.
- Affected units
- 269
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 (8)
- GTIN: 05055273200966 Lot Numbers: 1214UE
- 1249UE
- 1260UE
- 1262UE
- 1268UE
- 1297UE
- 1298UE
- 1315UE
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 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 · measurement bias
See all →- HighEmano Flow Uroflowmetry App Recalled Over Biased Flow Estimates
FDA (Devices) · 2026-07-29
- HighStago D-dimer assay shows positive bias across entire analytical range
FDA (Devices) · 2026-03-25
- HighCapillary tubes recalled over a positive bias in potassium results
FDA (Devices) · 2026-02-25
- HighVITROS Chemistry CRP Diagnostic Slides May Underreport Elevated Results
FDA (Devices) · 2024-12-04
- Highepoc BGEM BUN Test Cards recalled for sodium measurement bias
FDA (Devices) · 2024-11-13
Similar recalls
- HighRandox Clinical Chemistry Calibration Serum Recalled for Measurement Bias
FDA (Devices) · 2024-05-15
- ModerateRandox Calibration Serum Level 3 Recalled for Bilirubin Bias
FDA (Devices) · 2021-05-19
- LowRandox Calibration Serum Recalled for Incorrect Analyte Targets
FDA (Devices) · 2019-09-18
- HighMedical Device Calibration Serums Recalled Due to Instructional Transcription Errors
FDA (Devices) · 2024-01-24
- ModerateRandox CK MB Calibrator recalled due to calibration inaccuracy affecting test results
FDA (Devices) · 2022-05-25
- HighCalibration Serum with Mis-assigned Alkaline Phosphatase Target
FDA (Devices) · 2024-01-24