Drug recall
Beckman Coulter Lipase, REF OSR6130 and OSR6230.
FDA recall event 83583 · Class II · Beckman Coulter Inc.
Key facts
| Event ID | 83583 |
|---|---|
| Recall numbers | Z-0210-2020, Z-0211-2020 |
| Recalling firm | Beckman Coulter Inc. |
| Product type | Devices |
| Products | Beckman Coulter Lipase, REF OSR6130 and OSR6230., Beckman Coulter Uric Acid, REF OSR6098, OSR6198, and OSR6698. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | NAPQI, a metabolite of Acetaminophen, causes negative interference with the recalled product assays at levels present in the serum/plasma of overdose patients., NAPQI, a metabolite of Acetominophen, causes negative interference with the recalled product assays at levels present in the serum/plasma of overdose patients. |
| Initiation date | Aug 24, 2018 |
| Report date | Oct 30, 2019 |
| Termination date | Aug 2, 2024 |
| City | Brea |
| State | CA |
| Country | United States |
| FEI number | 2050012 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: