Expo32 ADC Software Version 1.1C, Part Number 6418337-New Users Software Kit, and Part Number 175454 Upgrade Software Ki

FDA device recall Z-0471-2007 · posted 2007-01-09 · Terminated

Recall details

Recalling firm

Beckman Coulter Inc

Reason for recall

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.

Action taken

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.

Root cause

Other

Status

Terminated

Product code

JQP

Quantity affected

28 units

Distribution

Nationwide including the states of MA, AL, CO, MI, IN, MD, MO NY, PA, TX, AR, CA, NJ, FL, and TN

Date initiated

2006-11-01

Date posted

2007-01-09

Date terminated

2012-02-27

Location

Brea, CA