Recall Z-1328-2024 ยท JIX Calibrator, Multi-Analyte Mixture
Randox Laboratories Ltd.
Liquid Protein Calibrators. C3 and Haptoglobin liquid protein calibrators used with Randox IgA, IgG, and IgM assays that require sample predilution.
| Date | Mar 20, 2024 (initiated Mar 1, 2024) |
| Status | Open, Classified |
| Reason | The firm has realigned C3 and Haptoglobin in Liquid Protein Calibrators, IT2691, to reference material ERM-DA470k/IFCC. |
| 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 technical.services@randox.com 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 o |
| Quantity | 1,764 units |
| Distribution | Domestic: CA, FL, IL, ME, NJ, OH, & OR. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K061056 | RANDOX LIQUID PROTEIN CALIBRATOR Randox Laboratories, Ltd., Jul 20, 2006 |