Z-0277-2012

SoftLab GUI versions 4.0.2.8-4.0.2.10; 4.0.3.12-4.0.3.13; and 4.0.4.1-4.0.4.4. SoftLab is a laboratory...

Name: Z-0277-2012 SoftLab GUI versions 4.0.2.8-4.0.2.10; 4.0.3.12-4.0.3.13; and 4.0.4.1-4.0.4.4. SoftLab is a laboratory...
Creator: SCC Soft Computer
Published: 2011-05-03
License: https://open.fda.gov/license/

SCC Soft Computer / initiated 2011-05-03 / Terminated / root cause: software

FDA source

SCC Soft Computer began a recall of SoftLab GUI versions 4.0.2.8-4.0.2.10; 4.0.3.12-4.0.3.13; and 4.0.4.1-4.0.4.4. SoftLab is a laboratory information system to be used in a medical research or... on 2011-05-03. The reason FDA records is "On 05/03/2011 SCC Soft Computer, Clearwater, FL initiated a correction on the following SoftLab GUI versions 4.0.2.8-4.0.2.10; 4.0.3.12-4.0.3.13; and 4.0.4.1-4.0.4.4. A client reported the PT and INR results did not get...". 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-0277-2012
Status: Terminated
Initiated: 2011-05-03
Posted: 2011-11-23
Terminated: 2013-08-07
Recalling firm: SCC Soft Computer
Product: SoftLab GUI versions 4.0.2.8-4.0.2.10; 4.0.3.12-4.0.3.13; and 4.0.4.1-4.0.4.4. SoftLab is a laboratory information system to be used in a medical research or clinical laboratory by knowledgeable, trained, and experienced personnel. SoftLab enables the user to handle data-processing and laboratory activities, for the purpose of storing, managing, querying, and report laboratory data.
Product code: LNX
Reason for recall: On 05/03/2011 SCC Soft Computer, Clearwater, FL initiated a correction on the following SoftLab GUI versions 4.0.2.8-4.0.2.10; 4.0.3.12-4.0.3.13; and 4.0.4.1-4.0.4.4. A client reported the PT and INR results did not get flagged. The PROT should have been flagged as HIGH and the INR should have been flagged as PANIC. Neither test was flagged. All affected clients were notified of the issue on 05/03
Root cause tag: software
FDA root cause: Software design
Action: SCC Soft Computer initiated a Field correction on May 3, 2011. All customers with affected software have been notified of this issue. Clients were instructed to have a "valcheck" utility run to determine if there are any tests in their system affected by the issue. They were supposed to indicate whether they wanted to schedule to receive the patch or hot fix. If you have any further questions please call ( 727 ) 789-0100.
Quantity in commerce: 69
Distribution: Worldwide Distribution-- USA ( nationwide) and Canada.
Product codes and lots: SoftLab GUI versions 4.0.2.8-4.0.2.10; 4.0.3.12-4.0.3.13; and 4.0.4.1-4.0.4.4.

Product code LNX

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)