Reported Apr 3, 2024 · Ongoing
Cystatin C Calibrator - In vitro diagnostic (IVD) use in the calibration of the Randox Cystatin C assay on automated…
Randox Laboratories Ltd.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Randox Laboratories Ltd. · 55 Diamond Road · Crumlin (North), N/A · N/A
Is this the product you have?
- Cystatin C Calibrator - In vitro diagnostic (IVD) use in the calibration of the Randox Cystatin C assay
- on automated analysers Catalog NumberCVS 2699
- Lot codes and dates
- GTIN05055273207439 (1) Batch 600957 Lot 1378CY - 1382CY (2) Batch 621809, 621815 Lot 1403CY - 1407CY (3) Batch 650533 Lot 1414CY - 1418CY
- Amount recalled
- 666 units
Where it was sold
Why it was recalled
Cystatin C Calibrator Series CVS 2699, is running with a negative bias compared to other methods
This product could cause temporary or reversible health problems — stop using it.
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