Class I Recall for Beckman Coulter. 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.
Root cause of the problem might be related maintenance
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.