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Recall Observatory FDA recall evidence

Device product

SYNCHRON Systems Direct LDL Cholesterol (LDLD) Reagent, REF: 969706

Z-0441-2026

September 17, 2025

Class II

Product summary

Firm
Beckman Coulter Inc.
Event
Event 97628
Status
Ongoing
Classification
Class II
Quantity
2,932 units
Official record key
device-enforcement:Z-0441-2026

Official wording

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.

Code information: REF: 969706. Lot: M404166. Expiration Date: 30Nov2025

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.