Z-1038-2015 Class II Terminated
FDA device recall Z-1038-2015 was initiated by SCC Soft Computer on May 20, 2014 and is designated Class II. Reason for recall: The interface fails to send abnormal flags for Reference Lab test results. The recall status is terminated (terminated May 16, 2016). Affected quantity: 48.
Recall Details
- Product Type
- Devices
- Report Date
- February 11, 2015
- Initiation Date
- May 20, 2014
- Termination Date
- May 16, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 48
Product Description
SoftLab with SA HIS versions 4.0.7.0-4.0.7.1 SoftLab is a laboratory information system to be used in a medical research or clinical laboratory.
Reason for Recall
The interface fails to send abnormal flags for Reference Lab test results.
Distribution Pattern
Distributed US (nationwide) in the states of OH, GA, NJ, WI, FL, NH, IL, NY, IN, CA, AL, VA, MO, MI, KY, MA, PA, CO, ME, TN, WA, MN, SD, LA, NC, and NV and the country of Canada.
Code Information
4.0.7.0: released 12/13/13 - present 4.0.7.1: released 02/28/14 - present