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Terminated

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 or clinical laboratory.

FDA Recall Z-1038-2015 · Posted 2015-02-02

Recalling FirmSCC Soft Computer
Recall StatusTerminated
Product CodeJQP
Date Initiated2014-05-20
Date Terminated2016-05-16
Product Quantity48

Reason for Recall

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

Firm Action

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

Distribution Pattern

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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