Cystatin C Calibrator Series CVS 2699 Recalled for Calibration Bias
Randox Laboratories is recalling Cystatin C Calibrator Series CVS 2699 because it runs with negative bias compared to other methods, which could affect test accuracy on automated analyzers.
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 medical device recall with no reported illnesses or injuries. The device presents a risk of harm through calibration bias that could affect diagnostic accuracy, fitting the 'High' severity category per the rubric where injury has not yet been reported.
Plain-English summary
Randox Laboratories Ltd. is recalling the Cystatin C Calibrator Series CVS 2699 (Catalog Number CVS 2699), an in vitro diagnostic device used to calibrate Cystatin C assays on automated analyzers. A total of 666 units were distributed nationwide in California and Indiana.
The device is being recalled because it runs with a negative bias compared to other methods. This calibration error could result in inaccurate test results on automated analyzer systems that use this calibrator.
Affected healthcare facilities and laboratories should discontinue use of this product immediately and contact Randox Laboratories for instructions on device replacement or return.
The recalled product
- Product
- Cystatin C Calibrator - In vitro diagnostic (IVD) use in the calibration of the Randox Cystatin C assay on automated analysers Catalog Number: CVS 2699
- Manufacturer
- Randox Laboratories Ltd.
- Hazard
- calibration-bias
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 (2)
- GTIN: 05055273207439 (1) Batch 600957 Lot 1378CY - 1382CY (2) Batch 621809
- 621815 Lot 1403CY - 1407CY (3) Batch 650533 Lot 1414CY - 1418CY
Distribution
Distributed nationwide across the United States.
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