FDA recall Z-2181-2019

Ortho Clinical Diagnostics · Class II · device

Product

VITROS 4600 Chemistry System, clinical chemistry analyzer

Reason for recall

Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System

Distribution

Worldwide distribution. US nationwide including Puerto Rico, Brazil, Canada, Chile, France, India, and Philippines.

Key facts

Status: Terminated
Initiation date: 2019-07-08
Report date: 2019-08-14
Termination date: 2023-10-19
Voluntary/Mandated: Voluntary: Firm initiated
Location: Rochester, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2181-2019