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U.S. Department of Health and Human Services

Medical Devices

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Beckman Coulter, Inc., Synchron LX Clinical Systems Ion Selective Electrolyte (ISE) Flow Cell

Recall Class: Class I

Date Recall Initiated: April 5, 2011

Product: Synchron LX Clinical Systems Ion Selective Electrolyte (ISE) Flow Cell

The following model numbers are affected by this recall.

  • LX20 - 466200,
  • LX20 PRO - 476100
  • LXi 725 - 476501

The products were distributed from March 1997 to April 2011.

Use:

These systems are computer-controlled clinical chemistry analyzers used to determine different types of blood chemistries and other chemistries from blood samples collected from an individual. Analyses are performed on a variety of fluids including blood, urine, and cerebrospinal fluid.

Recalling Firm:

Beckman Coulter, Inc.
250 South Kramer Boulevard
Brea, California 92821-6208

Reason for Recall:

There may be ratio pump wear, silver iodide build-up on the chloride electrode, microbial contamination, general non-ISE hardware, and maintenance in the instruments (ion selective electrolyte flow cell) which may cause incorrect electrolyte results. This may cause serious adverse health consequences or death.

Public Contact:

Customers may contact the Beckman Coulter Customer Support Center at http://www.beckmancoulter.com/customersupport/support/disclaimer icon or by calling Beckman Coulter at 1-800-854-3633, or through their local Beckman Coulter representative.

FDA District: Los Angeles

FDA Comments:

On April 5, 2011, the company sent its customers a Product Corrective Action letter including a customer response form. The company informed their customers of the affected products, the issue, the impact, and the actions to be taken. Customers were advised of the:

  • incorrect electrolyte problem that may occur from maintenance-related issues
  • ratio pump wear
  • silver iodide build-up on the chloride electrode
  • microbial contamination in the instruments (ion selective electrolyte flow cell)

The company requested customers to:

  • follow the new maintenance instructions included in the letter.
  • complete and return the response form enclosed in the letter within 10 days.
  • share the information with their laboratory staff.
  • retain the notice as part of their laboratory Quality System documentation.

Based on the available information at this time, it appears that the root cause may be a maintenance-related issue. However, the root cause has not been definitively determined and it is recommended that the laboratories maintain a level of vigilance to assess whether the change in maintenance routine resolves the issue.

Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to the FDA’s MedWatch Adverse Event Reporting MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.