Class II — Beckman Coulter Inc.
| Recalling firm | BECKMAN COULTER, INC. |
|---|---|
| Registered facility | View this company's 22 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | NAPQI, a metabolite of Acetaminophen, causes negative interference with the recalled product assays at levels present in the serum/plasma of overdose patients. |
| Product | Beckman Coulter Lipase, REF OSR6130 and OSR6230. |
| Quantity | 20,926 units |
| Distribution | Distribution was nationwide. There was government and military distribution. Foreign distribution was made to Canada. |
| Initiated | 2018-08-24 |
| Classified | 2019-10-24 |
| Terminated | 2024-08-02 |
| Recall number | Z-0210-2020 |
| 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 — Beckman Coulter Inc. (Z-0210-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/83583/
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