Reported Nov 12, 2025 · Ongoing
SYNCHRON Systems Direct LDL Cholesterol (LDLD) Reagent, REF: 969706
Beckman Coulter Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Beckman Coulter Inc. · 250 S Kraemer Blvd · Brea, CA · 92821-6232
Is this the product you have?
- SYNCHRON Systems Direct LDL Cholesterol (LDLD) Reagent
- REF969706
- Lot codes and dates
- REF969706
- LotM404166
- Expiration Date30Nov2025
- Amount recalled
- 2,932 units
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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