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 | Randox Laboratories has identified that Inorganic Phosphate in Calibration Serum Level 3, CAL2351 & CAL10388, is running with a negative bias on RX Series instruments compared to other methods. |
| Product | Clinical Chemistry Calibration Serum (Catalog number Cal2351) that is 20x5ml lyophilized human based serum covering 38 commonly used clinical chemistry tests. |
| Quantity | 80,366 units (US: 242 units; OUS: 80,094 units) |
| Distribution | Domestic: Nationwide Distribution. |
| Initiated | 2024-03-05 |
| Classified | 2024-05-03 |
| Recall number | Z-1759-2024 |
| 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-1759-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/94358/
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