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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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.
- 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.
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