Recall Z-2143-2012— SCC Soft Computer

Class II FDA medical device recall by SCC Soft Computer, initiated 2011-10-17, terminated 2014-09-03. FDA's recall record names no specific 510(k) clearance for this event. Product: SoftLab with SA INST versions: 3.1.6.12, 4.0.1.26-4.0.1.32, 4.0.2.21-4.0.2.51, and 4.0.3.5-4.0.3.13. Product UsageSoftLab 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 reporting laboratory data.. Reason: On 10/17/2011 SCC Soft Computer, Clearwater, FL initiated a correction on SoftLab with SA INST versions: 3.1.6.12, 4.0.1.26-4.0.1.32, 4.0.2.21-4.0.2.51, and 4.0.3.5-4.0.3.13. A client reported an issue which caused two different sets of results from the Sysmex series of Hematology instruments to display under the same order on the instrument menu..

Recalling firm

SCC Soft Computer

Classification

Class II

Status

Terminated

Initiated

2011-10-17

Terminated

2014-09-03

Firm location

Clearwater, FL, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.