Randox Laboratories Ltd. Recall 92781
Description: 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
Randox Laboratories Ltd. Recall 92781 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2448-2023 |
| Event ID | 92781 |
| Event Description | 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 Type | Devices |
| Distribution | CA, FL, IL, ME, MI, NC, OH, PA,NJ, |
| Quantity | 166 units |
| Recall 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. |
| Device Classification | 20230830 |
| Device Code Info | GTIN: 05055273204032 Batch/ Lot number Expiry Date 590858 28 08 23; 590859 28 08 23; 627222 28Jul 24; 627224 28Jul24; 634886 28Jul24; 634887 28Jul24 |
| Center Classification Date | 20230823 |
| Recall Initiation Date | 20230719 |
| Recalling Firm | Randox Laboratories Ltd. |
| Initial Notification | |
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