SoftPath GUI versions: 4.2.3.3-4.2.3.6 and 4.3.0.5-4.3.0.12. SoftPath is a laboratory information system to be used in a

FDA device recall Z-0363-2012 · posted 2011-12-02 · Terminated

Recall details

Recalling firm

SCC Soft Computer

Reason for recall

On 07/20/2011 SCC Soft Computer, Clearwater, FL, initiated a correction on the following SoftPath GUI versions: 4.2.3.3-4.2.3.6 and 4.3.0.5-4.3.0.12. A client reported that the HPV results on a patient report were incorrect. The HPV results were from the previous order on the patient and not the current order. All affected clients were notified about the issue on 07/20/2011.

Action taken

SCC Soft Computer sent a "CORRECTION COMMUNICATION" dated July 20, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. SCC personnel will review the customized Lab Results AP macro and/or the Micro Results AP macro on customer systems and will either discuss with them the irregularities requiring change or reconfigure macros as necessary.

Root cause

Software design

Status

Terminated

Product code

JQP

Quantity affected

97

Distribution

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

Date initiated

2011-07-20

Date posted

2011-12-02

Date terminated

2013-05-21

Location

Clearwater, FL