Class II — Randox Laboratories Ltd.
| Recalling firm | RANDOX LABORATORIES, LTD. |
|---|---|
| Registered facility | View this company's 4 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | The firm has realigned C3 and Haptoglobin in Liquid Protein Calibrators, IT2691, to reference material ERM-DA470k/IFCC. |
| Product | Liquid Protein Calibrators. C3 and Haptoglobin liquid protein calibrators used with Randox IgA, IgG, and IgM assays that require sample predilution. |
| Quantity | 1,764 units |
| Distribution | Domestic: CA, FL, IL, ME, NJ, OH, & OR. |
| Initiated | 2024-03-01 |
| Classified | 2024-03-20 |
| Recall number | Z-1328-2024 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Randox Laboratories Ltd. (Z-1328-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/94187/
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