Z-2865-2017 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- August 9, 2017
- Initiation Date
- May 31, 2017
- Termination Date
- August 4, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 18 units
Product Description
SoftLab Software Laboratory information system to be used in a medical research or clinical laboratory by knowledgeable, trained,
Reason for Recall
Display of lab results based on incorrect LOINC code/test descriptions for tests that were performed at a reference lab, saved incorrectly, and sent to systems that display the EMR.
Distribution Pattern
US Distribution to states of: CA, IL, LA, MA, MD, MI, MN, NJ, NY, PA, and TX.
Code Information
Versions 4.5.4.3, 4.5.4.5, 4.5.4.6, 4.5.4.8, 4.5.4.9, 4.5.4.20, 4.5.4.30, 4.5.4.40, 4.5.5.0, 4.5.5.10, and 4.5.5.20