Z-2448-2023Class II

Randox Liquid Protein Calibrators-SP CAL-(LIQ)-In vitro diagnostic product used for the calibration of ASO...

Name: Z-2448-2023 Randox Liquid Protein Calibrators-SP CAL-(LIQ)-In vitro diagnostic product used for the calibration of ASO...
Creator: Randox Laboratories Ltd.
Published: 2023-07-19
License: https://open.fda.gov/license/

Randox Laboratories, Limited / initiated 2023-07-19 / Open, Classified / root cause: manufacturing process

FDA source

Randox Laboratories Ltd. began a recall of Randox Liquid Protein Calibrators-SP CAL-(LIQ)-In vitro diagnostic product used for the calibration of ASO, Complement C3, Complement C4, CRP, Ferritin... on 2023-07-19. FDA classified it as Class II and gives the reason as "As part of the firm's ongoing quality monitoring (see internal complaint # OCC72574), Randox Laboratories have restandardized Ferritin in Liquid Protein Calibrators, IT2691, to reference material NISBC 19/118. The...". 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-2448-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-07-19
Posted: 2023-08-23
Recalling firm: Randox Laboratories, Limited
Product: Randox Liquid Protein Calibrators-SP CAL-(LIQ)-In vitro diagnostic product used for the calibration of ASO, Complement C3, Complement C4, CRP, Ferritin, Haptoglobin, IgM, Prealbumin, RF and Transferrin assays Catalogue Number: IT2691
Product code: JIX Calibrator, Multi-Analyte Mixture
Reason for recall: As part of the firm's ongoing quality monitoring (see internal complaint # OCC72574), Randox Laboratories have restandardized Ferritin in Liquid Protein Calibrators, IT2691, to reference material NISBC 19/118. The calibrators lots 2112IT-2116IT, packed into batches 627222, 627224, 634886 and 634887 have been reassigned as part of the restandardization. Following this restandardization, Ferritin results for Quality Control material and patient samples recovered erroneously higher than the targeted calibrator values by approximately +10% across the assay range following.
Root cause tag: manufacturing process
FDA root cause: Under Investigation by firm
Action: Randox Labs Ltd (Manufacturer) extended recall to the US distributor via Medical Device Correction Letter dated July 19, 2023. The distributor initial contact with customer and follow up contacts via email and telephone. Letter states reason for recall, health risk and action to take: " Review results generated with the affected batches in line with the clinical profile of the patient. " 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. Transmission of Field Safety Notice: Send a copy of the FSN to all affected customers and to those who need to be aware within your organisation. If you have any questions or concerns please contact Rand ox Technical Services. Any customers using batches 590858 and 590859 for Ferritin, please contact [email protected]
Quantity in commerce: 166 units
Distribution: CA, FL, IL, ME, MI, NC, OH, PA,NJ,
Product codes and lots: GTIN: 05055273204032 Batch/ Lot number Expiry Date 590858 28 08 23; 590859 28 08 23; 627222 28Jul 24; 627224 28Jul24; 634886 28Jul24; 634887 28Jul24

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2448-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2448-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-30	2023-08-23

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)