SYNCHRON Systems Direct LDL Cholesterol (LDLD) Reagent, REF: 969706
| Source | FDA Device Enforcement |
|---|---|
| Category | Medical Device |
| Severity | Medium |
| Status | ongoing |
| Recall date | September 17, 2025 |
| Reported | November 12, 2025 |
| Recalling firm | Beckman Coulter Inc. |
| Country / region | United States CA |
Hazard
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 discovered internally and confirmed on August 19, 2025 by Beckman Coulter.
Affected products
- SYNCHRON Systems Direct LDL Cholesterol (LDLD) Reagent, REF: 969706
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