ClearanceBrief
Recall Z-0466-2012 ยท JQP Calculator/Data Processing Module, For Clinical Use

SCC Soft Computer

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 repo

DateJan 11, 2012 (initiated Aug 25, 2011)
StatusTerminated
ReasonOn 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
Root causeSoftware design
ActionSCC 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.
Quantity144
DistributionWorldwide Distribution -- USA (nationwide) and Canada.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.