Class III — 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 III |
| Status | Terminated |
| Reason | The ACTH in Immunoassay Premium and Premium Plus quality control does not meet the quoted reconstituted stability claim in the product IFU. |
| Product | Immunoassay Premium Controls (3x4x5mL and 12x5mL packages) |
| Quantity | 117 Kits |
| Distribution | Distribution US nationwide. |
| Initiated | 2017-08-11 |
| Classified | 2018-03-12 |
| Terminated | 2019-03-29 |
| Recall number | Z-0969-2018 |
| 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 III recall — Randox Laboratories (Z-0969-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/79076/
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