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 | Amylase AY3805 batch 480449 and Pancreatic Amylase AY3855 batch 480483 have failed to meet the quoted performance claims prior to expiry on 28th Sept 2020. |
| Product | Amylase AY3805 batch 480449 Amylase Ethylidene Blocked-pNPG7 Reagent |
| Quantity | 1497 units |
| Distribution | New Mexico, Massachusetts, WV. Foreign distribution to Bolivia BOSNIA AND HERZEGOVINA Brazil Colombia Costa Rica Cyprus Egypt France Greece Grenada India Iraq Italy Jordan Kazakhstan Kenya Lithuania Mauritius Nepal Nigeria Pakistan Peru Philippines Poland Portugal Qatar Romania Russia South Africa Thailand The Bahamas Turkey UAE UK Vietnam |
| Initiated | 2020-07-10 |
| Classified | 2020-08-28 |
| Terminated | 2021-06-17 |
| Recall number | Z-2923-2020 |
| 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-2923-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/86114/
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