SoftLab used with SA INST 4.0.2.0 to 4.0.2.51, 4.0.3.0 to 4.0.3.13, 4.5.0.0 to 4.5.0.9, 4.5.2.0 to 4.5.2.8 and SA INST 3

FDA device recall Z-0444-2012 · posted 2012-01-11 · Terminated

Recall details

Recalling firm

SCC Soft Computer

Reason for recall

SCC Soft Computer, Clearwater, FL, initiated a correction for the SoftLab used with SA INST. A test performed on the Roche Cobas Integra series of instruments when used with the GenInst/Dispatch listening program could cause incorrect flagging for a test result posted to the lab database.

Action taken

The firm, SCC Soft Computer, sent a "Correction Communication" letter on July 26, 2011 to customers/consignees. The letter describes the product problem and actions to be taken. The firm will correct the software to recognize and support all known formats of the resulting date and time sent by an instrument. The software is available via a recommended patch or hot fix to the client's current release. The customers were asked to acknowledge receipt of the task and grant permission for SCC to correct the affected configuration files. If you have any questions, call (727) 789-0100.

Root cause

Software design

Status

Terminated

Product code

JQP

Quantity affected

265

Distribution

Worldwide Distribution - USA (Nationwide) and Country of: Canada.

Date initiated

2011-07-26

Date posted

2012-01-11

Date terminated

2013-05-21

Location

Clearwater, FL