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Z-1038-2015 Class II Terminated

Recalled by SCC Soft Computer — Clearwater, FL

Recall Details

Product Type: Devices
Report Date: February 11, 2015
Initiation Date: May 20, 2014
Termination Date: May 16, 2016
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 48

Product Description

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.

Reason for Recall

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

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.

Code Information

4.0.7.0: released 12/13/13 - present 4.0.7.1: released 02/28/14 - present