The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1065-2015·Announced 2015-02-18

SCC Soft Computer Recalls SoftPath Laboratory Information System Versions

SCC Soft Computer is recalling specific versions of the SoftPath Laboratory Information System because diagnostic text modifications may not be saved or displayed correctly.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 a software defect that could lead to incorrect diagnostic reporting, which is a risk-of-harm product where injury has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

SCC Soft Computer is recalling specific versions of the SoftPath Laboratory Information System, including versions 4.3.0.8 through 4.3.0.15 and 4.4.0.0. The recall involves 108 units that were distributed in the United States and Canada.

The recall was initiated because modifications to diagnostic text may be saved to the database but not appear on the report sent to the physician, or they may be documented on the report but not saved to the database. This defect could result in discrepancies between the data stored in the system and the reports provided to healthcare providers.

Healthcare facilities using the affected software versions should contact SCC Soft Computer for instructions on how to resolve the issue. The recall is classified as Class II by the FDA, indicating a reasonable probability that use of the product could cause temporary or medically reversible health adverse effects.

The recalled product

Product
SoftPath Laboratory Information System. Versions 4.3.0.8, 4.3.0.9, 4.3.0.10, 4.3.0.11, 4.3.0.12, 4.3.0.14, 4.3.0.15, and 4.4.0.0
Manufacturer
SCC Soft Computer
Category
Medical Device — Laboratory Information System
Hazard
Affected units
108

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 (8)

  • Version 4.3.0.8 Release date: 07/31/2009 - Present
  • Version 4.3.0.9 Release date: 11/23/2009 - Present
  • Version 4.3.0.10 Release date: 09/20/2010- Present
  • Version 4.3.0.11 Release date: 11/11/2010- Present
  • Version 4.3.0.12 Release date: 02/07/2011- Present
  • Version 4.3.0.14 Release date: 11/14/2012- Present
  • Version 4.3.0.15 Release date: 09/17/2013- Present
  • Version 4.4.0.1 Release date: 12/13/2013 - Present

Distribution

Distributed nationwide across the United States.

Related recalls

Same manufacturer · SCC Soft Computer

See all →

Same hazard · data integrity

See all →

Similar recalls