Z-0751-2024Class II

Calibration Serum Level 3. CAL 3, REF CAL2351. Human Assayed Multi-Sera Level 2 (HN1530) Human Assayed...

Name: Z-0751-2024 Calibration Serum Level 3. CAL 3, REF CAL2351. Human Assayed Multi-Sera Level 2 (HN1530) Human Assayed...
Creator: Randox Laboratories Ltd.
Published: 2023-11-13
License: https://open.fda.gov/license/

Randox Laboratories, Limited / initiated 2023-11-13 / Open, Classified / root cause: labeling and UDI

FDA source

Randox Laboratories Ltd. began a recall of Calibration Serum Level 3. CAL 3, REF CAL2351. Human Assayed Multi-Sera Level 2 (HN1530) Human Assayed Multi-Sera Level 3 (HE 1532) on 2023-11-13. FDA classified it as Class II and gives the reason as "There have been transcription errors on the Instructions For Use (IFU) of the Calibration Serum Level 3 (CAL2351 lot 1260UE, 1262UE and 1315UE) for target values of Bilirubin and Triglycerides, on the IFU of Human...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0751-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-11-13
Posted: 2024-01-18
Recalling firm: Randox Laboratories, Limited
Product: Calibration Serum Level 3. CAL 3, REF CAL2351. Human Assayed Multi-Sera Level 2 (HN1530) Human Assayed Multi-Sera Level 3 (HE 1532)
Product code: JIX Calibrator, Multi-Analyte Mixture
Reason for recall: There have been transcription errors on the Instructions For Use (IFU) of the Calibration Serum Level 3 (CAL2351 lot 1260UE, 1262UE and 1315UE) for target values of Bilirubin and Triglycerides, on the IFU of Human Assayed Multi-Sera Level 2 (HN1530) for TBIC taget value and on IFU of Human Assayed Multi-Sera Level 3 (HE 1532) for Lipase target value.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: On November 20, 2023, the firm notified customers via Medical Device Correction letter. The letter consisted of three parts. This recall record covers the third part, which concerned transcription errors in the Instructions for Use (IFU) for the above listed products. Customers should discard all copies of the IFUs and download the latest versions from www.randox.com. Customers should discuss the contents of the recall notice with their Medical Director if they have used the incorrect target value for any of the affected products.
Distribution: US Nationwide distribution.
Product codes and lots: UDI-DI: 05055273200966, lot1260UE, exp. 28 Nov 2024; lot 1262UE, exp. 28 Jan 2025; and lot 1315UE, exp. 28 May 2025

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0751-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0751-2024	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)