—#49668

Product

Expo32 ADC Software Version 1.1C, Part Number 6418337-New Users Software Kit, and Part Number 175454 Upgrade Software Kit used with the Coulter EPICS XL Flow Cytometers

FDA product code: JQP — Calculator/Data Processing Module, For Clinical Use
Device class: Class 1
Medical specialty: Clinical Chemistry
Affected lot / code info: all codes with the Software version

Why it was recalled

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.

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Beckman Coulter Inc
Address: 200 S Kraemer Blvd, Brea, California 92822-6208

Distribution

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

Timeline

Recall initiated: 2006-11-01
Posted by FDA: 2007-01-09
Terminated: 2012-02-27
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #49668. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.