Recall Z-2098-2021— Soft Computer Consultants, Inc.

Name: FDA recall Z-2098-2021
Creator: U.S. Food and Drug Administration
Published: 2021-03-31

Class II · Terminated

Class II FDA medical device recall by Soft Computer Consultants, Inc., initiated 2021-03-31, terminated 2023-02-14. FDA's recall record names no specific 510(k) clearance for this event. Product: SoftCytogenetics. Reason: Software is given wrong results going out to HIS on test that had reruns..

Recalling firm: Soft Computer Consultants, Inc.
Classification: Class II
Status: Terminated
Initiated: 2021-03-31
Terminated: 2023-02-14
Firm location: Clearwater, FL, United States

Product description

SoftCytogenetics

Reason for recall

Software is given wrong results going out to HIS on test that had reruns.

Data sourced from openFDA. This site is unofficial and independent of the FDA.