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Terminated

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.

FDA Recall Z-1573-2014 · Posted 2014-05-09

Recalling FirmSCC Soft Computer
Recall StatusTerminated
Product CodeJQP
Date Initiated2014-01-29
Date Terminated2014-11-03
Product Quantity1

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.

Firm 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.

Root Cause

Software design

Distribution Pattern

Distributed in IL.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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