Synchron LX Clinical Systems Ion Selective Electrolyte (ISE) Flow Cell Recalled due to Potential for Incorrect Results

Laboratory healthcare personnel and Risk Managers are informed by the US FDA that Synchron LX Clinical Systems Ion Selective Electrolyte (ISE) Flow Cell is recalled because there is a potential for incorrect electrolyte results leading to serious adverse events or death.

Background of Synchron LX Clinical Systems Ion Selective Electrolyte (ISE) Flow Cell

Synchron LX Clinical Systems Ion Selective Electrolyte (ISE) Flow Cell, by Beckman Coulter Inc., are clinical chemistry analyzers controlled by computer. They are used for the determination of different types of blood chemistries and other chemistries from blood samples and a variety of fluids including cerebrospinal fluid and urine. FDA Alert on Synchron LX Clinical Systems Ion Selective Electrolyte (ISE) Flow Cell

FDA’s reason for the recall is that microbial contamination, ratio pump wear, general non-ISE hardware, silver iodide build-up on the chloride electrode and maintenance in the instruments that may cause incorrect electrolyte results leading to serious adverse events or death.

The affected model numbers are: LX20 – 466200, LX20 PRO – 476100 and LXi 725 – 476501.

The distribution dates were from March 1997 to April 2011.

The FDA classified this recall as Class I, meaning use of the products included in the recall may cause serious injuries or death.

Recommendation on Synchron LX Clinical Systems Ion Selective Electrolyte (ISE) Flow Cell

“On April 5, 2011, the company sent its customers a Product Corrective Action letter including a customer response form. The company requested customers to follow the new maintenance instructions included in the letter.

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.”

Contacting the FDA to report cases with Synchron LX Clinical Systems Ion Selective Electrolyte (ISE) Flow Cell

In case of detection of adverse events or side effects related to the use of Synchron LX Clinical Systems Ion Selective Electrolyte (ISE) Flow Cell, healthcare professionals and patients should report it to the FDA’s MedWatch Safety Information and Adverse Event Reporting program through any of the following ways:

The report can be completed and submitted online at: www.fda.gov/MedWatch/report.htm

The form can be downloaded or requested by calling 1-800-332-1088, then completed and returned on the address indicated on the form

The completed form can be faxed to: 1-800-FDA-0178

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