The Recall Desk
HighFDA (Devices)·Z-0441-2026·Announced 2025-11-12

LDL cholesterol reagent recalled over increased probability of false high results

Beckman Coulter is recalling 2,932 units of SYNCHRON Systems Direct LDL Cholesterol reagent from one lot because it may generate false high results.

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: Scored 3 under the risk-of-harm criterion: falsely high results can misrepresent a patient's condition, and no injuries are reported.

Plain-English summary

The Beckman Coulter SYNCHRON Systems Direct LDL Cholesterol (LDLD) Reagent, REF 969706, is being recalled.

Beckman Coulter identified an increased probability that reagent lot M404166 may generate false high results. The firm states the issue was discovered internally and confirmed on 19 August 2025.

The recall covers 2,932 units from lot M404166, expiring 30 November 2025, distributed worldwide including in Alabama, Arkansas, California, Florida, Georgia, Hawaii, Iowa, Idaho, Kansas, Kentucky, Louisiana, Massachusetts, Maryland and Maine. The FDA has classified the action as Class II.

A falsely high LDL result can misrepresent a patient's cardiovascular risk. Laboratories holding lot M404166 should stop using it and follow Beckman Coulter's instructions.

The recalled product

Product
SYNCHRON Systems Direct LDL Cholesterol (LDLD) Reagent, REF: 969706
Manufacturer
Beckman Coulter Inc.
Category
Medical Device — Diagnostic reagent
Hazard
  • erroneous-results
  • false-high
  • in-vitro-diagnostic

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.

Related recalls

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