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 | Terminated |
| Reason | When calibrating using the standard provided in the kit, the change in absorbance is lower than expected generating internal quality control results high outside range |
| Product | RANDOX CHOL-cholesterol (total) test system intended to measure cholesterol in plasma and serum REF: CH200 |
| Quantity | 15 kits |
| Distribution | US Nationwide distribution in the states of GA, OR, PA ,WA, West Virginia. |
| Initiated | 2021-11-01 |
| Classified | 2021-12-01 |
| Terminated | 2023-03-09 |
| Recall number | Z-0328-2022 |
| 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-0328-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/88999/
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