FDA Device recall Z-0441-2026
SYNCHRON Systems Direct LDL Cholesterol (LDLD) Reagent, REF: 969706
- FDA Device
- Class II
- ongoing
- Published 2025-11-12
On 2025-11-12 the FDA classified a Class II recall of SYNCHRON Systems Direct LDL Cholesterol (LDLD) Reagent, REF: 969706 by Beckman Coulter, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0441-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-09-17 |
| Published | 2025-11-12 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Beckman Coulter |
| Distribution | US |
Product
SYNCHRON Systems Direct LDL Cholesterol (LDLD) Reagent, REF: 969706
Reason
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.
Identifiers
| code_info | REF: 969706. Lot: M404166. Expiration Date: 30Nov2025 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0441-2026%22
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