Z-1038-2015Class II

SoftLab with SA HIS versions 4.0.7.0-4.0.7.1 SoftLab is a laboratory information system to be used in a...

Name: Z-1038-2015 SoftLab with SA HIS versions 4.0.7.0-4.0.7.1 SoftLab is a laboratory information system to be used in a...
Creator: SCC Soft Computer
Published: 2014-05-20
License: https://open.fda.gov/license/

SCC Soft Computer / initiated 2014-05-20 / Terminated / root cause: design

FDA source

SCC Soft Computer began a recall of SoftLab with SA HIS versions 4.0.7.0-4.0.7.1 SoftLab is a laboratory information system to be used in a medical research or clinical laboratory on 2014-05-20. FDA classified it as Class II and gives the reason as "The interface fails to send abnormal flags for Reference Lab test results". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1038-2015
Classification: Class II
Status: Terminated
Initiated: 2014-05-20
Posted: 2015-02-02
Terminated: 2016-05-16
Recalling firm: SCC Soft Computer
Product: SoftLab with SA HIS versions 4.0.7.0-4.0.7.1 SoftLab is a laboratory information system to be used in a medical research or clinical laboratory.
Product code: JQP Calculator/Data Processing Module, For Clinical Use
Reason for recall: The interface fails to send abnormal flags for Reference Lab test results.
Root cause tag: design
FDA root cause: Device Design
Action: The firm sent out 2 CORRECTION COMMUNICATIONS informing consignees of functionality in release of 4.0.7 HIS Add-on interfaces which SCC has designated to be a potential patient Risk-to-Health issue. Further the corrective action indicated HIS releases 4.0.7.2 and higher will be corrected. Hot Fixes have been developed for HIS Add-on patches 4.0.7.0 and 4.0.7.1. Lastly the communication requests that the user "please acknowledge receipt of this task and grant permission to load the mandatory hot fix(es). Thank you."
Quantity in commerce: 48
Distribution: Distributed US (nationwide) in the states of OH, GA, NJ, WI, FL, NH, IL, NY, IN, CA, AL, VA, MO, MI, KY, MA, PA, CO, ME, TN, WA, MN, SD, LA, NC, and NV and the country of Canada.
Product codes and lots: 4.0.7.0: released 12/13/13 - present 4.0.7.1: released 02/28/14 - present

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1038-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1038-2015	Class II	Terminated	Voluntary: Firm initiated	2015-02-11	2015-02-02

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)