Soft Computer Consultants, Inc.: Medical Device Recall in 2017 - (Recall #: Z-2865-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.
Product Description:

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

Product Classification:

Class II

Date Initiated: May 31, 2017
Date Posted: August 9, 2017
Recall Number: Z-2865-2017
Event ID: 77669
Reason for Recall:

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.

Status: Terminated
Product Quantity: 18 units
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.

Voluntary or Mandated:

Voluntary: Firm initiated