[pending] SYNCHRON Systems Direct LDL Cholesterol (LDLD) Reagent, REF: 969706
Pending LLM rewrite. Source: FDA_DEVICE Z-0441-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
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.
The recalled product
- Product
- SYNCHRON Systems Direct LDL Cholesterol (LDLD) Reagent, REF: 969706
- Manufacturer
- Beckman Coulter Inc.
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- REF: 969706. Lot: M404166. Expiration Date: 30Nov2025
Distribution
Distributed nationwide across the United States.
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