Class I Medical Device Recall: Beckman Coulter, Inc., Synchron LX Clinical Systems Ion Selective Electrolyte (ISE) Flow Cell
Posted May 23 2011 12:00am
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.
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.
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.
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.