Z-0441-2026 Class II Ongoing
FDA device recall Z-0441-2026 was initiated by Beckman Coulter Inc. on September 17, 2025 and is designated Class II. 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 disco… The recall status is ongoing. Affected quantity: 2,932 units.
Recall Details
- Product Type
- Devices
- Report Date
- November 12, 2025
- Initiation Date
- September 17, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,932 units
Product Description
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.
Distribution Pattern
Worldwide - US Nationwide distribution in the states of AL, AR, CA, FL, GA, HI, IA, ID, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NJ, NM, NY, OH, OK, OR, PA, PR, QC, SC, TX, WA, WV and the country of Canada.
Code Information
REF: 969706. Lot: M404166. Expiration Date: 30Nov2025