Beckman Coulter Inc Coulter LH700 Series Hematology Analyzers, Part Number 6605632 with 2B Software (2B3, 2B4 and 2B5) Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

There is a potential for erroneous yet credible results for Body Fluids on the LH700 series hematology analyzers when a cassette label fails to read and the subsequent sample is cycled in Body Fluid mode.

Recommended Action

Per FDA guidance

A Product Corrective Action (PCA) letter was mailed on Sep 12, 2006 to all LH 750 accounts to inform them that there is an issue with COULTER LH 700 Series analyzer software that could affect the Body Fluid analysis and that this this anomaly is present only in Software revisions of 2B. The letter instructs the customer on how to determine their software version. Immediate user preventive action was provided in the letter which is to reset the analyzer when a cassette label read error occurs. The letter advises that this information be shared with laboratory staff and be retained as part of their Quality System documentation. A customer response form was also included.