Recall Z-2448-2023 ยท JIX Calibrator, Multi-Analyte Mixture
Randox Laboratories Ltd.
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
| Date | Aug 23, 2023 (initiated Jul 19, 2023) |
| Status | Open, Classified |
| Reason | 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 | 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 technical.services@randox.com within five working days. Transmission of Field Safety Notice: |
| Quantity | 166 units |
| Distribution | CA, FL, IL, ME, MI, NC, OH, PA,NJ, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K061056 | RANDOX LIQUID PROTEIN CALIBRATOR Randox Laboratories, Ltd., Jul 20, 2006 |