Cystatin C Calibrator — Class II medical device recall Z-1369-2024
Ongoing recall by Randox Laboratories Ltd., reported 2024-04-03, distributed nationwide. Cystatin C Calibrator Series CVS 2699, is running with a negative bias compared to other methods
| Recall number | Z-1369-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Randox Laboratories Ltd., Crumlin (North), N/A, Ireland |
| Recall initiated | 2024-02-14 |
| Classified | 2024-03-22 |
| Reported by FDA | 2024-04-03 |
| Distributed | Nationwide (US) |
| Quantity | 666 units |
| UPC / GTIN / UDI-DI | 05055273207439 |
| Lot numbers | 1378CY, 1382CY, 1403CY, 1407CY, 1414CY, 1418CY, 600957, 621809, 621815, 650533 |
| Model numbers | 2699 |
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1369-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.