# FDA recall Z-1369-2024

> **Randox Laboratories Ltd.** · Class II · device recall initiated 2024-02-14.

## 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

## Reason for recall

Cystatin C Calibrator Series CVS 2699, is running with a negative bias compared to other methods

## Distribution

US Nationwide distribution in the states of CA, IN.

## Key facts

- **Recall number:** Z-1369-2024
- **Recalling firm:** Randox Laboratories Ltd.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-02-14
- **Report date:** 2024-04-03

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Crumlin (North), N/A, Ireland

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1369-2024

## Citation

> AI Analytics. FDA recall Z-1369-2024. Retrieved 2026-06-10 from https://api.ai-analytics.org/recall/Z-1369-2024. Source: US FDA. Licensed CC0.

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