Z-0753-2024Class II

Calibration Serum Level 3 - IVD For use as a Calibrator in clinical chemistry assays Catalog Number: CAL2351

Name: Z-0753-2024 Calibration Serum Level 3 - IVD For use as a Calibrator in clinical chemistry assays Catalog Number: CAL2351
Creator: Randox Laboratories Ltd.
Published: 2023-11-20
License: https://open.fda.gov/license/

Randox Laboratories, Limited / initiated 2023-11-20 / Open, Classified

FDA source

Randox Laboratories Ltd. began a recall of Calibration Serum Level 3 - IVD For use as a Calibrator in clinical chemistry assays Catalog Number: CAL2351 on 2023-11-20. FDA classified it as Class II and gives the reason as "Target for Alkaline Phosphatase (ALP) for the AMP optimized to IFCC 37C method has been mis-assigned for the RX Series instruments by approximately 10% on Quality Control and patient samples". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0753-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-11-20
Posted: 2024-01-18
Recalling firm: Randox Laboratories, Limited
Product: Calibration Serum Level 3 - IVD For use as a Calibrator in clinical chemistry assays Catalog Number: CAL2351
Product code: JIX Calibrator, Multi-Analyte Mixture
Reason for recall: Target for Alkaline Phosphatase (ALP) for the AMP optimized to IFCC 37C method has been mis-assigned for the RX Series instruments by approximately 10% on Quality Control and patient samples
FDA root cause: Under Investigation by firm
Action: Randox issued Urgent Medical Device Correction letter on 11/20/23 to the distribution center within the USA. The US distributor contacted the customer direct via email. Letter states reason for recall, health risk and action to take: Review your calibrator inventory of this lot and assess your laboratories needs for reimbursement for discarded inventory. " Discuss the contents of this notice with your Medical Director. " Complete and return the response form, 12187-QA to [email protected] within five working days. If you have any questions or concerns please contact Randox Technical Services.
Quantity in commerce: 108 kits
Distribution: US Nationwide including Puerto Rico.
Product codes and lots: GTIN: 05055273200966 Lot/Batch No: 1214UE Exp. Date: 28 Nov 2023

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0753-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0753-2024	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)