SCC Soft Computer: Medical Device Recall in 2012 - (Recall #: Z-2143-2012)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: October 17, 2011

Date Posted: August 15, 2012

Recall Number: Z-2143-2012

Event ID: 62023

Reason for Recall:

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.

Status: Terminated

Product Quantity: 88

Code Information:

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.

Distribution Pattern:

US Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated