The Recall Desk
HighFDA (Devices)·Z-2865-2017·Announced 2017-08-09

SoftLab Software Recalled for Incorrect Lab Result Display

Soft Computer Consultants is recalling SoftLab Software versions 4.5.4.3 through 4.5.5.20 because it may display lab results based on incorrect LOINC codes.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves incorrect display of lab results, which is a risk-of-harm product issue where injury has not yet been reported, fitting the High severity criteria.

Plain-English summary

Soft Computer Consultants, Inc. is recalling 18 units of SoftLab Software, a laboratory information system used in medical research or clinical laboratories. The recall affects specific software versions, including 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.

The recall was initiated because the software may display lab results based on incorrect LOINC codes or test descriptions. This issue occurs for tests performed at a reference lab that were saved incorrectly and subsequently sent to systems that display the Electronic Medical Record (EMR).

The affected software was distributed in the United States to the states of California, Illinois, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, New Jersey, New York, Pennsylvania, and Texas. Users of the affected software versions should contact the manufacturer for instructions on correcting the data or updating the system.

The recalled product

Product
SoftLab Software Laboratory information system to be used in a medical research or clinical laboratory by knowledgeable, trained,
Manufacturer
Soft Computer Consultants, Inc.
Category
Medical Device — Laboratory Information System
Hazard
Affected units
18

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (11)

  • 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

Distributed in 11 states:

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