Z-0752-2024Class II

Calibration Serum Level 3 CAL2351

Name: Z-0752-2024 Calibration Serum Level 3 CAL2351
Creator: Randox Laboratories Ltd.
Published: 2023-11-20
License: https://open.fda.gov/license/

Randox Laboratories, Limited / initiated 2023-11-20 / Open, Classified / root cause: manufacturing process

FDA source

Randox Laboratories Ltd. began a recall of Calibration Serum Level 3 CAL2351 on 2023-11-20. FDA classified it as Class II and gives the reason as "CK Total in Calibration Serum Level 3, CAL2351, is running with a positive bias on RX Series instruments compared to other methods experience a shift in Quality Control and patient sample recovery of up to 13%". 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-0752-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-11-20
Posted: 2024-01-18
Recalling firm: Randox Laboratories, Limited
Product: Calibration Serum Level 3 CAL2351
Product code: JIX Calibrator, Multi-Analyte Mixture
Reason for recall: CK Total in Calibration Serum Level 3, CAL2351, is running with a positive bias on RX Series instruments compared to other methods experience a shift in Quality Control and patient sample recovery of up to 13%.
Root cause tag: manufacturing process
FDA root cause: Under Investigation by firm
Action: Randox issued Urgent Medical Device Correction Letter via email to the US and PR Distributors on 11/20/23. Distributors contacted the customer directly. The Letter states reason for recall, health risk and action to take: Action to be taken: " Discuss the contents of this notice with your Medical Director if you have used the RX Series targets for CK Total in the aforementioned lots. " Complete and return the response form, 12187-QA to [email protected] within five working days. " Please discard all copies of the IFUs and download the latest versions from www.randox.com. If you have any questions or concerns please contact Randox Technical Services.
Quantity in commerce: 269 kits
Distribution: US Nationwide and Puerto Rico.
Product codes and lots: GTIN: 05055273200966 Lot Numbers: 1214UE, 1249UE, 1260UE, 1262UE, 1268UE, 1297UE, 1298UE, 1315UE

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0752-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0752-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-01-24	2024-01-18

Product code JIX

K053153Class IIRandox Calibration SerumRandox Laboratories, Ltd. / cleared 2006-01-13

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)