Drug recall
SYNCHRON Systems Direct LDL Cholesterol (LDLD) Reagent, REF: 969706
FDA recall event 97628 · Class II · Beckman Coulter Inc.
Key facts
| Event ID | 97628 |
|---|---|
| Recall numbers | Z-0441-2026 |
| Recalling firm | Beckman Coulter Inc. |
| Product type | Devices |
| Products | SYNCHRON Systems Direct LDL Cholesterol (LDLD) Reagent, REF: 969706 |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Beckman Coulter has identified that there is an increased probability Synchron Systems Direct LDL Cholesterol (LDLD REF 969706) reagent lot M404166 may generate false high results. The issue was… |
| Initiation date | Sep 17, 2025 |
| Report date | Nov 12, 2025 |
| 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: