FDA Recall Terminated

BD FACSDiva Software v6.0 and 6.1 with the HP XW4400 Computer System Model/Catalog number 642685 Software is used to simplify acquisition of flow cytometry data.

Recall: Z-1530-2008 · Initiated December 21, 2007

Recall

Recall Number
Z-1530-2008
Event Number
46372
Firm
BD Biosciences
FEI Number
2916837
Product Code
GKZ
Status
Terminated
Root Cause
Software design
Initiated
December 21, 2007
Posted
August 8, 2008
Terminated
September 24, 2008
Address
2350 Qume Dr, San Jose, CA, 95131-1807

Description

BD FACSDiva Software v6.0 and 6.1 with the HP XW4400 Computer System Model/Catalog number 642685 Software is used to simplify acquisition of flow cytometry data.

Reason

Values might not update in statistics views after certain functions are performed in a worksheet.

Action

The firm issued an Important Product Information notification letter on 12/21/2007. The letter instructs users to reload data by closing and reopening an experiment before reporting results in order to determine if their statistics have been impacted. They are asked to fill out and return a form pertaining to this problem. BD Biosciences will release a version of BD FACSDiva software to correct this problem. The letter also stated that BD Biosciences rep will contact the users when the new software is available. User are asked to contact BD Customer Support Center at 1-877-232-8995 if they have any additional questions.

Distribution

Nationwide Distribution.

Quantity

74 units