Z-1573-2014Class II

SCC SA HIS version 4.0.7.0 when used with SoftMic version 4.0.7.0. SoftMic is a laboratory information system...

Name: Z-1573-2014 SCC SA HIS version 4.0.7.0 when used with SoftMic version 4.0.7.0. SoftMic is a laboratory information system...
Creator: SCC Soft Computer
Published: 2014-01-29
License: https://open.fda.gov/license/

SCC Soft Computer / initiated 2014-01-29 / Terminated / root cause: software

FDA source

SCC Soft Computer began a recall of SCC SA HIS version 4.0.7.0 when used with SoftMic version 4.0.7.0. SoftMic is a laboratory information system to be used in medical results, clinical, and... on 2014-01-29. FDA classified it as Class II and gives the reason as "When an isolate is resulted without a SNOMED code, isolate information in the downstream system may be incomplete or missing. As a result, there is the potential for the delay or omission of patient treatment updates". 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-1573-2014
Classification: Class II
Status: Terminated
Initiated: 2014-01-29
Posted: 2014-05-09
Terminated: 2014-11-03
Recalling firm: SCC Soft Computer
Product: SCC SA HIS version 4.0.7.0 when used with SoftMic version 4.0.7.0. SoftMic is a laboratory information system to be used in medical results, clinical, and public health laboratories by knowledgeable, trained, and experienced personnel. SoftMic enables the user to handle data processing and laboratory activities for microbiology and serology testing, for the purpose of storing, managing, querying, and reporting laboratory data.
Product code: JQP Calculator/Data Processing Module, For Clinical Use
Reason for recall: When an isolate is resulted without a SNOMED code, isolate information in the downstream system may be incomplete or missing. As a result, there is the potential for the delay or omission of patient treatment updates.
Root cause tag: software
FDA root cause: Software design
Action: On 2/10/2014 SCC Soft Computer used a proprietary task management system to send a Correction Communication to the consignee with the affected software. The letter identifies the product, problem and corrective actions.
Quantity in commerce: 1
Distribution: Distributed in IL.
Product codes and lots: SA HIS version 4.0.7.0

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1573-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1573-2014	Class II	Terminated	Voluntary: Firm initiated	2014-05-21	2014-05-09

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)