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Recall Observatory FDA recall evidence

Device product

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.

Z-1038-2015

May 20, 2014

Class II

Product summary

Firm
SCC Soft Computer
Event
Event 70021
Status
Terminated
Classification
Class II
Quantity
48
Official record key
device-enforcement:Z-1038-2015

Official wording

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

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

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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