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%.
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: 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.
- Hazard
- measurement-bias
- calibration-error
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
Distributed nationwide across the United States.
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