Z-1369-2024Class II

Cystatin C Calibrator - In vitro diagnostic (IVD) use in the calibration of the Randox Cystatin C assay on...

Name: Z-1369-2024 Cystatin C Calibrator - In vitro diagnostic (IVD) use in the calibration of the Randox Cystatin C assay on...
Creator: Randox Laboratories Ltd.
Published: 2024-02-14
License: https://open.fda.gov/license/

Randox Laboratories, Limited / initiated 2024-02-14 / Open, Classified / root cause: manufacturing process

FDA source

Randox Laboratories Ltd. began a recall of Cystatin C Calibrator - In vitro diagnostic (IVD) use in the calibration of the Randox Cystatin C assay on automated analysers Catalog Number: CVS 2699 on 2024-02-14. FDA classified it as Class II and gives the reason as "Cystatin C Calibrator Series CVS 2699, is running with a negative bias compared to other methods". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1369-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-02-14
Posted: 2024-03-22
Recalling firm: Randox Laboratories, Limited
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
Product code: NDY Test, Cystatin C
Reason for recall: Cystatin C Calibrator Series CVS 2699, is running with a negative bias compared to other methods
Root cause tag: manufacturing process
FDA root cause: Under Investigation by firm
Action: Randox Laboratories Ltd, UK ( manufacturer) notified the US Distributor Randox Laboratories USA . The distributor initial contact and the follow up contact via email on 2/20/24. Letter states reason for recall, health risk and action to take: We have realigned the target values in the above lot numbers to the IFCC Reference Standard. Please refer to the table below for the updated calibrator targets. You may experience a positive shift in Quality Control and patient sample recovery. If you are using CVS 2699 batch 600957 lots 1378CY-1382CY please provide proof of scrappage and a replacement calibrator lot will be provided. Please discard all copies of the calibrator Instructions For Use (IFU)s and download the updated IFUs from www.randox.com. If further information is required, please contact [email protected] . In line with the realignment to the Cystatin C Calibrator Series, we are updating the target and range for the Cystatin C controls, CYS5019 and CYS5020. The updated target and range can be found in the table below. Please discard any copies of the IFU and download the updated version from www.randox.com.
Quantity in commerce: 666 units
Distribution: US Nationwide distribution in the states of CA, IN.
Product codes and lots: GTIN: 05055273207439 (1) Batch 600957 Lot 1378CY - 1382CY (2) Batch 621809, 621815 Lot 1403CY - 1407CY (3) Batch 650533 Lot 1414CY - 1418CY

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1369-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1369-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-04-03	2024-03-22

Product code NDY

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)