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Class I Recall for Beckman Coulter Synchron LX Clinical Systems ISE Flow Cell

May 24, 2011 | Parker Waichman LLP

Beckman Coulter Inc. has issued a Class I recall for its Synchron LX Clinical Systems Ion Selective Electrolyte (ISE) Flow Cell.   According to the recall notice, the system may return incorrect electrolyte results.

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.

According to Beckman Coulter, 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.

While a preliminary investigation indicated the root cause of the problem might be related maintenance,   Beckman Coulter says this is not certain.  As such, laboratories are advised to maintain a level of vigilance to assess whether the change in maintenance routine resolves the issue.

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.

Beckman Coulter informed customers of this issue in a Product Corrective Action letter dated April 5.  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.

Class 1 recalls are the U.S. Food & Drug Administration's  (FDA)  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.



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