SoftMic GUI versions: 4.0.3.0-4.0.3.15, 4.0.4.1-4.0.4.7. SoftMic is a laboratory information system to be used in medica

FDA device recall Z-0466-2012 · posted 2012-01-11 · Terminated

Recall details

Recalling firm

SCC Soft Computer

Reason for recall

On 08/25/2011, SCC Soft Computer initiated a correction on the following SoftMic GUI versions: 4.0.3.0-4.0.3.15, 4.0.4.1-4.0.4.7. For clients using SoftMic Result Entry, when a certain series of keystrokes on the test grid are performed while entering results and statusing a test, the test status may not be maintained upon saving. The status may be removed or copied from another test on the order

Action taken

SCC Soft Computer initiated a Field Correction dated August 25, 2011. to all affected customers. Customers with the affected software have been notified and are scheduling receipt of the hot fix.. Further questions call (727) 789-0100.

Root cause

Software design

Status

Terminated

Product code

JQP

Quantity affected

144

Distribution

Worldwide Distribution -- USA (nationwide) and Canada.

Date initiated

2011-08-25

Date posted

2012-01-11

Date terminated

2014-10-03

Location

Clearwater, FL