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 | An issue was identified where the software froze during processing of commands, which resulted in no results displayed. |
| Product | Randox RX Imola Analyser with ISE, Catalog Numbers RX4900, RX4900R |
| Quantity | 50 kits |
| Distribution | US Nationwide Distribution and Puerto Rico. |
| Initiated | 2021-04-28 |
| Classified | 2021-07-06 |
| Terminated | 2021-12-03 |
| Recall number | Z-2013-2021 |
| 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-2013-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/88098/
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