Recall – Defective blood bank software distributed

Company: Blood Bank Computer Systems, Inc
Date of Enforcement Report: 10/7/2020
Class II

PRODUCT

ABO QuickPass Web Portal, Version 1.2.0; ABO QuickPass Web Portal 1.1.0; ABO QuickPass Web Portal 1.0.0

Recall Number: B-0697-2020

REASON

Blood Bank software, with a defect or glitch, was distributed.

RECALLING FIRM/MANUFACTURER

Blood Bank Computer Systems, Inc. on 9/16/2020. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

17

DISTRIBUTION

U.S. Nationwide

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

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.