Inc Sunquest Information Systems

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.

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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