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Terminated

SoftMic GUI versions: 4.0.3.0-4.0.3.15, 4.0.4.1-4.0.4.7. SoftMic is a laboratory information system to be used in medical research, 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-0466-2012 · Posted 2012-01-11

Recalling FirmSCC Soft Computer
Recall StatusTerminated
Product CodeJQP
Date Initiated2011-08-25
Date Terminated2014-10-03
Product Quantity144

Reason for Recall

On 08/25/2011, SCC Soft Computer initiated a correction on the following SoftMic GUI versions: 4.0.3.0-4.0.3.15, 4.0.4.1-4.0.4.7. For clients using SoftMic Result Entry, when a certain series of keystrokes on the test grid are performed while entering results and statusing a test, the test status may not be maintained upon saving. The status may be removed or copied from another test on the order

Firm Action

SCC Soft Computer initiated a Field Correction dated August 25, 2011. to all affected customers. Customers with the affected software have been notified and are scheduling receipt of the hot fix.. Further questions call (727) 789-0100.

Root Cause

Software design

Distribution Pattern

Worldwide Distribution -- USA (nationwide) and Canada.

Official Source

View FDA Recall →

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

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