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 Ammonia reagents are being recalled from the field due to a positive bias of up to 140mol/l being observed on patient samples. |
| Product | AM1015 Randox Ammonia (NH3), Enzymatic UV Method For the quantitative in vitro determination of Ammonia in plasma |
| Quantity | 143 kits in total |
| Distribution | US Distribution to states of: VA, UT, WV and country of : Canada |
| Initiated | 2020-07-30 |
| Classified | 2020-09-14 |
| Terminated | 2021-02-03 |
| Recall number | Z-2965-2020 |
| 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-2965-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/86238/
Alerts for RANDOX LABORATORIES, LTD.
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.