SoftLab with SA HIS versions 4.0.7.0-4.0.7.1 SoftLab is a laboratory information system to be used in a medical research

FDA device recall Z-1038-2015 · posted 2015-02-02 · Terminated

Recall details

Recalling firm

SCC Soft Computer

Reason for recall

The interface fails to send abnormal flags for Reference Lab test results.

Action taken

The firm sent out 2 CORRECTION COMMUNICATIONS informing consignees of functionality in release of 4.0.7 HIS Add-on interfaces which SCC has designated to be a potential patient Risk-to-Health issue. Further the corrective action indicated HIS releases 4.0.7.2 and higher will be corrected. Hot Fixes have been developed for HIS Add-on patches 4.0.7.0 and 4.0.7.1. Lastly the communication requests that the user "please acknowledge receipt of this task and grant permission to load the mandatory hot fix(es). Thank you."

Root cause

Device Design

Status

Terminated

Product code

JQP

Quantity affected

48

Distribution

Distributed US (nationwide) in the states of OH, GA, NJ, WI, FL, NH, IL, NY, IN, CA, AL, VA, MO, MI, KY, MA, PA, CO, ME, TN, WA, MN, SD, LA, NC, and NV and the country of Canada.

Date initiated

2014-05-20

Date posted

2015-02-02

Date terminated

2016-05-16

Location

Clearwater, FL