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Recall Observatory FDA recall evidence

Device product

SoftLab Software Laboratory information system to be used in a medical research or clinical laboratory by knowledgeable, trained,

Z-2865-2017

May 31, 2017

Class II

Product summary

Firm
Soft Computer Consultants, Inc.
Event
Event 77669
Status
Terminated
Classification
Class II
Quantity
18 units
Official record key
device-enforcement:Z-2865-2017

Official wording

Reason: Display of lab results based on incorrect LOINC code/test descriptions for tests that were performed at a reference lab, saved incorrectly, and sent to systems that display the EMR.

Code information: Versions 4.5.4.3, 4.5.4.5, 4.5.4.6, 4.5.4.8, 4.5.4.9, 4.5.4.20, 4.5.4.30, 4.5.4.40, 4.5.5.0, 4.5.5.10, and 4.5.5.20

Distribution pattern: US Distribution to states of: CA, IL, LA, MA, MD, MI, MN, NJ, NY, PA, and TX.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Display of lab results based on incorrect LOINC code/test descriptions for tests that were performed at a reference lab, saved incorrectly, and sent to systems that display the EMR.