Recall of Blood Bank and Blood Donor Software

DATE RECALL INITIATED:

August 24, 2001

PRODUCT / LOT NUMBER / EXPIRATION DATE:

FlexiLab Blood Bank and Blood Donor Software, Software versions 5.2, 5.23, and 5.3

MANUFACTURER:

Sunquest Information Systems, Inc.
Tucson, AZ

REASON:

Due to a software defect there is a potential that blood components/derivatives could reach “Available Inventory Status” without completion of a review for unacceptable product testing results.

Pending modification of the software, when performing a type I component preparation, when the input unit is entered incorrectly, do NOT select (M) to modify the input unit number from the Accept (A), Modify (M), Reject (R) prompt. Instead, reject the preparation by selecting (R) and begin again.

The information in this listing reflects CBER's best efforts to communicate information that has been reported to FDA. Its accuracy and comprehensiveness cannot be guaranteed.