FDA recall Z-2178-2019

Ortho Clinical Diagnostics · Class II · device

Product

VITROS Chemistry Products Calibrator Kit 32, for use with VITROS 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-2178-2019