Device Recall Beckman Coulter Expo 32 ADC 의 리콜

Recall

36958

Class 2

Z-0471-2007

2006-11-01

2007-01-09

Terminated

United States

2012-02-27

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49668

The firm has confirmed that the ratio parameter assignments (numerator and denominator) of a protocol may inadvertently change after the parameter selection dialog box is accessed. this issue is limited to only protocols utilizing the ratio parameter.

A Product corrective Action (PCA) letter was mailed on 11/1/06 to Expo 32 software accounts. They are informed that the ratio parameter assignments (numerator and denominator) of a protocol may inadvertently change after the Parameter Selection Dialogue box is accessed. The issue is limited to only protocols utilizing the Ratio parameter. An immediate user preventive action to remedy this issue each time acquisition of samples that require a protocol utilizing the ratio parameter is desired is given within the letter: 1) Perform acquisition of samples in batches which use protocols containing the same ratio parameter assignments. 2) Before running samples, open the protocol intended for use and open the Parameter Selection dialog box to ensure the correct ratio parameter assignments for numerator and denominator are selected. Make any necessary changes and save the protocol. 3) Run samples. (Letter was sent by US mail). A response form is included.