SoftMic Versions 4.0.4.7, 4.5.1.3. Version 4.0.4.7 Manufactured 02/03/2010. Version 4.5.1.3 Manufactured 03/18/2010. SCC

FDA device recall Z-0088-2011 · posted 2010-10-19 · Terminated

Recall details

Recalling firm

SCC Soft Computer

Reason for recall

Softmic system may delay or omit reporting of clinically significant results including organisms and drug sensitivities. Incomplete culture results may appear complete. SCC Soft Computer is issuing a Correction for SoftMic Versions 4.0.4.7-4.5.1.3 software due to this potential hazard.

Action taken

SCC Soft Computer issued Risk-to-Health notifications to clients on July 19, 2010 via proprietary communication software. Corrective actions will be via programming correction via hot fix (software modification) or such so that Global variable is not used. Clients are asked to acknowledge receipt of this task and update the task with permission to load the required correction.

Root cause

Software design

Status

Terminated

Product code

LNX

Quantity affected

35

Distribution

Worldwide Distribution: USA, including the states of CA, CT, DE, FL, IA, KY, MA, MA, MI, MN, NJ, NY, OH, PA, TX, VA, and WI, and the country of Canada.

Date initiated

2010-07-19

Date posted

2010-10-19

Date terminated

2012-07-16

Location

Clearwater, FL