Randox Laboratories Ltd. Recall: Randox Liquid Protein Calibrators-SP CAL-(LIQ)-In vitro d
Randox Laboratories Ltd. Recall: Randox Liquid Protein Calibrators-SP CAL-(LIQ)-In vitro d is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Randox Laboratories Ltd.; Product: Randox Liquid Protein Calibrators-SP CAL-(LIQ)-In vitro diagnostic product used for the calibration of ASO, Comp
| Recalling firm | Randox Laboratories Ltd. |
|---|---|
| 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 |
| 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. |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Ongoing |
| Distribution | CA, FL, IL, ME, MI, NC, OH, PA,NJ, |
| Recall initiated | 20230719 |
| Recall number | Z-2448-2023 |
| Category | device |
| State | N/A |
| Country | Ireland |
$29/mo
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