SoftLab GUI versions 4.0.2.8-4.0.2.10; 4.0.3.12-4.0.3.13; and 4.0.4.1-4.0.4.4. SoftLab is a laboratory information syste

FDA device recall Z-0277-2012 · posted 2011-11-23 · Terminated

Recall details

Recalling firm

SCC Soft Computer

Reason for recall

On 05/03/2011 SCC Soft Computer, Clearwater, FL initiated a correction on the following SoftLab GUI versions 4.0.2.8-4.0.2.10; 4.0.3.12-4.0.3.13; and 4.0.4.1-4.0.4.4. A client reported the PT and INR results did not get flagged. The PROT should have been flagged as HIGH and the INR should have been flagged as PANIC. Neither test was flagged. All affected clients were notified of the issue on 05/03

Action taken

SCC Soft Computer initiated a Field correction on May 3, 2011. All customers with affected software have been notified of this issue. Clients were instructed to have a "valcheck" utility run to determine if there are any tests in their system affected by the issue. They were supposed to indicate whether they wanted to schedule to receive the patch or hot fix. If you have any further questions please call ( 727 ) 789-0100.

Root cause

Software design

Status

Terminated

Product code

LNX

Quantity affected

69

Distribution

Worldwide Distribution-- USA ( nationwide) and Canada.

Date initiated

2011-05-03

Date posted

2011-11-23

Date terminated

2013-08-07

Location

Clearwater, FL