Randox CK MB Calibrator recalled due to calibration inaccuracy affecting test results
Randox Laboratories has recalled the CK MB Calibrator (lot 4410CK) because it requires recalibration. When used without proper realignment, the calibrator produces test results approximately 6% higher than actual values.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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: This is an FDA Class III medical device recall with no reported illnesses or injuries. The hazard is a calibration inaccuracy producing a 6% systematic measurement error in test results. FDA Class III recalls are typically scored 1–2; this is a precautionary recall addressing a known, addressable issue.
Plain-English summary
Randox Laboratories Ltd. has recalled the CK MB Calibrator, Catalogue Number CK2393 (lot 4410CK). This product is used in clinical laboratories to calibrate equipment that measures cardiac biomarkers (CK-MB enzymes) in patient blood samples. Approximately 1,392 units were distributed domestically to West Virginia and Puerto Rico, with additional distribution to numerous international markets.
The recalled lot requires recalibration using updated values. Laboratories that calibrate their equipment with this lot without proper realignment will experience a positive shift of approximately 6% in test results. This means both quality control samples and patient test results will read approximately 6% higher than their actual values.
Healthcare facilities and clinical laboratories that have received this product should contact Randox Laboratories to obtain and implement the corrected calibration values. Results generated with incorrect calibration may not represent patient samples accurately. No illnesses or adverse events have been reported in connection with this recall.
The recalled product
- Product
- CK MB Calibrator, Catalogue Number CK2393
- Manufacturer
- Randox Laboratories Ltd.
- Affected units
- 1,392
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)
- GTIN 05055273201451 Lot 4410CK
Distribution
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