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 | Randox have confirmed imprecision of quality control and patient samples when using specific Randox Lipase buffer batches. |
| Product | Randox Lipase Assay: Lipase Colorimetric R1 Buffer - Product Usage: A Lipase test system is a device intended for the quantitative in vitro determination of Lipase in human serum and plasma. |
| Distribution | Worldwide distribution - US Nationwide distribution including in the states of Puerto Rico and WV. |
| Initiated | 2020-06-26 |
| Classified | 2020-08-04 |
| Terminated | 2020-10-19 |
| Recall number | Z-2752-2020 |
| 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-2752-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/86039/
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