DOD Blood Bank Class II 78 units

Defense Blood Standard System (DBSS), Blood Bank Software.

Recall #B-1094-9.

REASON

Blood bank computer software does not identify all potential
duplicate donor records.

CODE

Software Versions 3.00 and 3.01.

MANUFACTURER

Electronic Data Systems (EDS), Herndon, Virginia.

RECALLED BY

U.S. Department of Defense (DBSS)Composite Health Care System 2,
Falls Church, Virginia, by E-mail on June 9 and 16, 1999. Firm-initiated
field correction ongoing.

DISTRIBUTION

Nationwide and international.

QUANTITY

Utilized at 78 sites.

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.

What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:  https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices

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