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Biologic recalls tagged "Software defect"

Recalls of blood, tissue, vaccines and related products regulated by FDA’s biologics center, newest first. 5 recalls Each recall is dated by the day its recall page names (how recalls are dated).
Agency
Risk level
Status
Date
Sold in

1 recall that day

Biomedical Data Solutions Ortho Connect Software

Ortho Connect software can incorrectly reject potential discrepant results during result review.

Moderate risk, FDA, Ended, Software defect

1 recall that day

Diagnostic Grifols Erytra Analyzer

The Erytra analyzer can assign incorrect results for an autocancelled and rescheduled test, potentially leading to an incident if a transfusion is performed.

Moderate risk, FDA, Ended, Software defect

1 recall that day

Ortho-Clinical Diagnostics ORTHO VISION and ORTHO VISION Max Analyzers

Ortho Vision Analyzers and Ortho Vision Max Analyzers have a software anomaly that can cause incorrect association of samples and erroneous patient results.

Moderate risk, FDA, Ended, Software defect

2 recalls that day

Biomedical Data Solutions Complete Ortho Connect 3.x Software

Complete Ortho Connect 3.x Software has an issue with check rules that could lead to an incorrect result.

Moderate risk, FDA, Ended, Software defect

WellSky Transfusion Blood-Bank Management System

The WellSky Transfusion standalone blood-bank management system can fail to present a required soft-stop alert.

Moderate risk, FDA, Ended, Software defect