COULTER LH 700 Series 의 리콜

Recall

37287

Class 2

Z-0566-2007

2006-09-12

2007-03-06

Terminated

United States

2012-04-19

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=50283

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.

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.