SoftLab GUI versions: 3.18.1.0-3.18.1.21; 3.19.1.0-3.19.1.25; 3.19.2.0-3.19.2.21; 4.0.0.2; 4.0.1.0-4.0.1.16; 4.0.2.0-4.0

FDA device recall Z-0488-2012 · posted 2012-01-11 · 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: 3.18.1.0-3.18.1.21; 3.19.1.0-3.19.1.25; 3.19.2.0-3.19.2.21; 4.0.0.2; 4.0.1.0-4.0.1.16; 4.0.2.0-4.0.2.10; 4.0.3.0-4.0.3.16; 4.0.4.0-4.0.4.6; and 4.5.0.0-4.5.0.8. A client reported that results were not flagged correctly. This can occur when a test is ordered in Order Entry, then collected

Action taken

SCC Soft Computer sent a "CORRECTION COMMUNICATION" notification letter to all affected customers. The letter describes the product, Risk-to-Health notification task, potential hazard, and corrective action. The customers were asked to acknowledge receipt of the task and grant permission for SCC to make the required and recommended changes. For any questions, call (727) 789-0100.

Root cause

Software design

Status

Terminated

Product code

JQP

Quantity affected

220

Distribution

Worldwide Distribution - USA (nationwide) and the country of: Canada.

Date initiated

2011-05-03

Date posted

2012-01-11

Date terminated

2013-08-07

Location

Clearwater, FL