Randox Cystatin C Calibrator Recall: Negative Bias Risk in Lab Testing
Randox recalls specific batches of Cystatin C Calibrator (CVS 2699) due to negative bias in lab testing. Affected units may give inaccurate results for cystatin C assays.
Lower-risk recall
Cystatin C Calibrator Series CVS 2699, is running with a negative bias compared to other methods
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What happened, in plain English
Rando: Randox recalls certain batches of Cystatin C Calibrator (CVS 2699) because they run with a negative bias compared to other testing methods. This could lead to inaccurate lab results for cystatin C assays. Read more at govinfonow.com/recall/56163-randox-cystatin-c-calibrator-recall-negative-bias-risk-in-lab.
Source Summary by GovInfoNow · govinfonow.com/recall/56163-randox-cystatin-c-calibrator-recall-negative-bias-risk-in-lab · Updated August 18, 2026 · FDA enforcement record: FDA #Z-1369-2024
Cite this page
“Randox Cystatin C Calibrator Recall: Negative Bias Risk in Lab Testing.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/56163-randox-cystatin-c-calibrator-recall-negative-bias-risk-in-lab. Based on FDA recall #Z-1369-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1369-2024%22&limit=1).
Why it’s dangerous
The calibrator runs with a negative bias, meaning it may produce test results that are too low compared to other methods. This could lead to inaccurate cystatin C measurements in blood tests.
Who’s affected
Lab technicians and healthcare providers using Randox Cystatin C Calibrator for blood tests. Those using specific batch numbers are most at risk.
How to tell if you have this one
Check for the catalog number CVS 2699 and batch numbers: 600957 (Lot 1378CY-1382CY), 621809/621815 (Lot 1403CY-1407CY), or 650533 (Lot 1414CY-1418CY).
- Brand
Randox- Product
Cystatin C Calibrator - In vitro diagnostic (IVD) use in the calibration of the Randox Cystatin C assay on automated- Category
Medical device
What to do — step by step
Check Batch Numbers
Look for batch numbers on the calibrator label: 600957 (Lot 1378CY-1382CY), 621809/621815 (Lot 1403CY-1407CY), or 650533 (Lot 1414CY-1418CY).
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 2 states.
FDA distribution: “US Nationwide distribution in the states of CA, IN.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: California, Indiana.
Recall timeline
FDA published this recall 49 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-1369-2024 (February 14, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1369-2024 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.