FDA Device recall Z-1369-2024
Cystatin C Calibrator - In vitro diagnostic (IVD) use in the calibration of the Randox Cystatin C assay on automated analysers Catalog Numb…
- FDA Device
- Class II
- ongoing
- Published 2024-04-03
On 2024-04-03 the FDA classified a Class II recall of Cystatin C Calibrator - In vitro diagnostic (IVD) use in the calibration of the Randox Cystatin C assay on automated analysers Catalog Numb… by Randox Laboratories, citing cystatin C Calibrator Series CVS 2699, is running with a negative bias compared to other methods.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1369-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-02-14 |
| Published | 2024-04-03 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Randox Laboratories |
| Distribution | US |
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
Cystatin C Calibrator Series CVS 2699, is running with a negative bias compared to other methods
Identifiers
| code_info | GTIN: 05055273207439 (1) Batch 600957 Lot 1378CY - 1382CY (2) Batch 621809, 621815 Lot 1403CY - 1407CY (3) Batch 650533 Lot 1414CY - 1418CY |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1369-2024%22
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