The Recall Desk
HighFDA (Devices)·Z-1034-2013·Announced 2013-04-10

Beckman Coulter Synchron LXi 725 Clinical System Recalled for Defective Pulley

Beckman Coulter is recalling 83 Synchron LXi 725 Clinical Systems because a defective incubator belt pulley may create debris that falls into reaction vessels, potentially causing erroneous test 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: The recall involves a risk-of-harm product (medical device) where injury has not yet been reported, but the hazard (erroneous test results) is significant enough to warrant a High severity rating under the rubric for risk-of-harm products without reported illness.

Plain-English summary

Beckman Coulter Inc. is recalling 83 units of the Synchron LXi 725 Clinical System (Part # A15642, all serial numbers). The recall is due to a defective newly released aluminum incubator belt pulley that may rub against the light shield, causing the formation of debris.

This debris can fall into the reaction vessels (RVs), presenting a risk of erroneous test results. The Synchron LXi 725 Clinical System is an in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids.

The affected units were distributed worldwide, including the United States (nationwide) and numerous countries in Europe, Canada, and Djibouti. Users of these devices should contact Beckman Coulter for further instructions regarding the recall.

The recalled product

Product
Synchron LXi 725 Clinical System; P/N 107405S Product Usage: The Access Immunoassay Systems are in vitro diagnostic devices used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids.
Manufacturer
Beckman Coulter Inc.
Category
Medical Device — In Vitro Diagnostic
Hazard
Affected units
83

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 (2)

  • Part # A15642
  • All Serial Numbers

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 4 recalled by Beckman Coulter Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

Related recalls

Same manufacturer · Beckman Coulter Inc.

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Same hazard · erroneous test results

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