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 | Ongoing |
| Reason | Concentration of Rheumatoid Factor has decreased in Specific Protein Control Level 1-3 causing delay in reporting results due to Quality Controls running low outside range |
| Product | Liquid Assayed Specific Protein Control Level 2- In vitro diagnostic use, in the quality control of serum on clinical chemistry and immunoassay systems Catalog Number: PS2683 |
| Quantity | 115 units |
| Distribution | US Nationwide distribution in the states of CA, FL, OH,ME, MO, NC, NJ, PA, TN. |
| Initiated | 2022-11-22 |
| Classified | 2023-01-05 |
| Recall number | Z-0904-2023 |
| 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-0904-2023).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/91225/
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