Information Data Management Blood Bank Class ll

PRODUCTComponents and Distribution Information System (CDIS) Stand Alone Blood
Bank Software. Recall #B-1094-0.

REASON
Blood bank software contains a defect that results in not all products produced from a donation receiving the special donation properties that are applicable to donation.

CODE
All versions up to and including version 1.1.1.

MANUFACTURER
Information Data Management, Inc., Rosemont, Illinois.

RECALLED BY
Manufacturer, by telephone on July 5 and 6, 2000, and by letters dated
July 7, 11, and 17, 2000. Firm-initiated recall ongoing.

DISTRIBUTION
South Carolina, Hawaii, Ohio, Indiana, New Jersey, Missouri, Illinois,
Tennessee, Hong Kong, and the United Kingdom.

QUANTITY
Installed in 10 centers.

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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