FDA recall Z-2865-2017

Product

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

US Distribution to states of: CA, IL, LA, MA, MD, MI, MN, NJ, NY, PA, and TX.

Key facts

Status

Terminated

Initiation date

2017-05-31

Report date

2017-08-09

Termination date

2020-08-04

Voluntary/Mandated

Voluntary: Firm initiated

Location

Clearwater, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2865-2017