Z-1328-2024Class II

Liquid Protein Calibrators. C3 and Haptoglobin liquid protein calibrators used with Randox IgA, IgG, and IgM...

Name: Z-1328-2024 Liquid Protein Calibrators. C3 and Haptoglobin liquid protein calibrators used with Randox IgA, IgG, and IgM...
Creator: Randox Laboratories Ltd.
Published: 2024-03-01
License: https://open.fda.gov/license/

Randox Laboratories, Limited / initiated 2024-03-01 / Open, Classified / root cause: manufacturing process

FDA source

Randox Laboratories Ltd. began a recall of Liquid Protein Calibrators. C3 and Haptoglobin liquid protein calibrators used with Randox IgA, IgG, and IgM assays that require sample predilution on 2024-03-01. FDA classified it as Class II and gives the reason as "The firm has realigned C3 and Haptoglobin in Liquid Protein Calibrators, IT2691, to reference material ERM-DA470k/IFCC". 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-1328-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-03-01
Posted: 2024-03-20
Recalling firm: Randox Laboratories, Limited
Product: Liquid Protein Calibrators. C3 and Haptoglobin liquid protein calibrators used with Randox IgA, IgG, and IgM assays that require sample predilution.
Product code: JIX Calibrator, Multi-Analyte Mixture
Reason for recall: The firm has realigned C3 and Haptoglobin in Liquid Protein Calibrators, IT2691, to reference material ERM-DA470k/IFCC.
Root cause tag: manufacturing process
FDA root cause: Under Investigation by firm
Action: Consignees were sent a MEDICAL DEVICE CORRECTION NOTIFICATION dated 03/06/2024. The notification instructs consignees to review results generated with the affected batches in line with the clinical profile of the patient, discuss the contents of the provided recall notice with the facility's Medical Director, and complete and return the response form to [email protected] within five working days. The notice should be shared with all customers if product was further distributed and to those who need to be aware within consignee organizations. Consignees with questions should reach out to Randox Technical Services.
Quantity in commerce: 1,764 units
Distribution: Domestic: CA, FL, IL, ME, NJ, OH, & OR.
Product codes and lots: Catalog No. IT2691; GTIN 05055273204032; Batch No./Lot No. (Exp. Date): 647343/2154IT-2158IT (03/28/25), 647342/2154IT-2158IT (03/28/25), 634886/2112IT-2116IT (07/28/24), 634887/2112IT-2116IT (07/28/24), 627224/2112IT-2116IT (07/28/24), 627222/2112IT-2116IT (07/28/24)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1328-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1328-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-03-27	2024-03-20

Product code JIX

K061056Class IIRandox Liquid Protein CalibratorRandox Laboratories, Ltd. / cleared 2006-07-20

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)