Class III — 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 III |
| Status | Terminated |
| Reason | The target value for uptake is incorrect on the value sheet for an analyzer. The target value for this analyzer is listed as 43.8%U and should be 39.4%U. |
| Product | Immunoassay Premium Plus Controls, Model Numbers IA3109 and IA3112 Product Usage: This product is intended for in vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of analytes listed in the package insert |
| Quantity | 12 |
| Distribution | The products were distributed to the following US states: WV and Puerto Rico. |
| Initiated | 2019-02-07 |
| Classified | 2019-04-08 |
| Terminated | 2020-06-08 |
| Recall number | Z-1106-2019 |
| 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 III recall — Randox Laboratories Ltd. (Z-1106-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/82184/
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