DATE RECALL INITIATED< br> 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:
A software defect has the potential to result in blood components/derivates reaching inventory “Available Inventory Status” without a product testing review in Function BTR, when an incorrect unit number is corrected using the modify function.
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 form the Accept (A), Modify (M), Reject (R) prompt. Instead, reject the preparation by selecting (R) and begin again.
