Z-1759-2024Class II

Clinical Chemistry Calibration Serum (Catalog number Cal2351) that is 20x5ml lyophilized human based serum...

Name: Z-1759-2024 Clinical Chemistry Calibration Serum (Catalog number Cal2351) that is 20x5ml lyophilized human based serum...
Creator: Randox Laboratories Ltd.
Published: 2024-03-05
License: https://open.fda.gov/license/

Randox Laboratories, Limited / initiated 2024-03-05 / Open, Classified / root cause: manufacturing process

FDA source

Randox Laboratories Ltd. began a recall of Clinical Chemistry Calibration Serum (Catalog number Cal2351) that is 20x5ml lyophilized human based serum covering 38 commonly used clinical chemistry tests on 2024-03-05. FDA classified it as Class II and gives the reason as "Randox Laboratories has identified that Inorganic Phosphate in Calibration Serum Level 3, CAL2351 & CAL10388, is running with a negative bias on RX Series instruments 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-1759-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-03-05
Posted: 2024-05-03
Recalling firm: Randox Laboratories, Limited
Product: Clinical Chemistry Calibration Serum (Catalog number Cal2351) that is 20x5ml lyophilized human based serum covering 38 commonly used clinical chemistry tests.
Product code: JIX Calibrator, Multi-Analyte Mixture
Reason for recall: Randox Laboratories has identified that Inorganic Phosphate in Calibration Serum Level 3, CAL2351 & CAL10388, is running with a negative bias on RX Series instruments compared to other methods.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: Consignees were emailed a Medical Device Correction notice dated 3/5/2024 instructing them to discuss the contents of the notification with their facility's Medical Director if affected units have been used, replace the IFU for affected devices with the one provided with the notification, and complete and return the provided response form by email to technical [email protected] within five working days. Updated IFUs can be accessed at www.randox.com and questions can be directed to [email protected].
Quantity in commerce: 80,366 units (US: 242 units; OUS: 80,094 units)
Distribution: Domestic: Nationwide Distribution.
Product codes and lots: Catalogue No. CAL2351 & CAL10388; GTIN: 05055273200966; Lot No. 1260UE, 1262UE, 1295UE, 1297UE, 1298UE, 1315UE, 1325UE, 1326UE, 1295UE, & 1325UE.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1759-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1759-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-05-15	2024-05-03

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)