Class II — Randox Laboratories
| 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 | Abnormal premature termination of the software could affect the use of the analyser when running patient samples. The impact being a delay in reporting test results. |
| Product | RX Imola (RX4900) For Professional Use for the quantitative in vitro determination of various clinical chemistry tests. |
| Quantity | 41 analyzers |
| Distribution | US Distribution including Puerto Rico and the state of : West Virginia. |
| Initiated | 2018-05-04 |
| Classified | 2018-06-04 |
| Terminated | 2020-06-16 |
| Recall number | Z-2059-2018 |
| 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 (Z-2059-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/79968/
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