Z-0363-2012

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...

Name: Z-0363-2012 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...
Creator: SCC Soft Computer
Published: 2011-07-20
License: https://open.fda.gov/license/

SCC Soft Computer / initiated 2011-07-20 / Terminated / root cause: software

FDA source

SCC Soft Computer began a recall of 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 clinical laboratory by knowledgeable... on 2011-07-20. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0363-2012
Status: Terminated
Initiated: 2011-07-20
Posted: 2011-12-02
Terminated: 2013-05-21
Recalling firm: SCC Soft Computer
Product: 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 clinical laboratory by knowledgeable, trained, and experienced personnel. SoftPath enables the user to document steps in the receiving and processing of surgical, gynecological, medical cytological, and autopsy case specimens within the Pathology labs, for the purpose of generating Pathology reports for requesting physicians and label creation for identification of specimen/case material.
Product code: JQP Calculator/Data Processing Module, For Clinical Use
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.
Root cause tag: software
FDA root cause: Software design
Action: 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.
Quantity in commerce: 97
Distribution: Worldwide Distribution-USA (nationwide) and the country of Canada.
Product codes and lots: SoftPath GUI versions: 4.2.3.3-4.2.3.6 and 4.3.0.5-4.3.0.12.

Product code JQP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)