Drug recall
Beckman Coulter, Cholesterol Assay, Catalog No. OSR6X16
FDA recall event 70030 · Class II · Beckman Coulter Inc.
Key facts
| Event ID | 70030 |
|---|---|
| Recall numbers | Z-1023-2015, Z-1024-2015, Z-1025-2015, Z-1026-2015 |
| Recalling firm | Beckman Coulter Inc. |
| Product type | Devices |
| Products | Beckman Coulter, Cholesterol Assay, Catalog No. OSR6X16, Beckman Coulter, Lactate Assay, Catalog No. OSR6X93, Beckman Coulter, Lipase Assay, Catalog No. OSR6X30, Beckman Coulter, Uric Acid Assay, Catalog No. OSR6X98 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | N-Acetyl Cysteine (NAC), when administered in therapeutic concentrations for the treatment of acetaminophen overdose, interferes with the assays for these analytes: Cholesterol OSR6X16, Uric Acid… |
| Initiation date | Dec 15, 2014 |
| Report date | Feb 4, 2015 |
| Termination date | Feb 19, 2016 |
| 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: