Randox Liquid Protein Calibrators-SP CAL- — Class II medical device recall Z-2448-2023
Ongoing recall by Randox Laboratories Ltd., reported 2023-08-30, distributed in CA, FL, IL, ME, MI, NC, NJ, OH…. As part of the firm's ongoing quality monitoring (see internal complaint # OCC72574), Randox Laboratories have
| Recall number | Z-2448-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Randox Laboratories Ltd., Crumlin (North), N/A, Ireland |
| Recall initiated | 2023-07-19 |
| Classified | 2023-08-23 |
| Reported by FDA | 2023-08-30 |
| Distributed | CA, FL, IL, ME, MI, NC, NJ, OH, PA |
| Quantity | 166 units |
| Reason classes | potency |
| UPC / GTIN / UDI-DI | 05055273204032 |
| Lot numbers | 28JUL24, 590858, 590859, 627222, 627224, 634886, 634887 |
| Model numbers | IT2691 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2448-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.