SYNCHRON Systems Direct LDL Cholesterol — Class II medical device recall Z-0441-2026
Ongoing recall by Beckman Coulter Inc., reported 2025-11-12, distributed nationwide. Beckman Coulter has identified that there is an increased probability Synchron Systems Direct LDL Cholesterol
| Recall number | Z-0441-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter Inc., Brea, CA, United States |
| Recall initiated | 2025-09-17 |
| Classified | 2025-11-06 |
| Reported by FDA | 2025-11-12 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 2,932 units |
| Lot numbers | M404166 |
| Model numbers | 969706 |
| Expiration dates | 2025-11-30 |
Product
SYNCHRON Systems Direct LDL Cholesterol (LDLD) Reagent, REF: 969706
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 discovered internally and confirmed on August 19, 2025 by Beckman Coulter.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0441-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.