Recall Z-1090-2017— Roche Diagnostics Corporation

Class II · Terminated

Class II FDA medical device recall by Roche Diagnostics Corporation, initiated 2016-12-27, terminated 2017-08-04. FDA's recall record names no specific 510(k) clearance for this event. Product: cobas p 612 pre-analytical system; Pre-analytical sample handling that includes de-capping, Aliquotting and sorting of samples for analysis..

Recalling firm
Roche Diagnostics Corporation
Classification
Class II
Status
Terminated
Initiated
2016-12-27
Terminated
2017-08-04
Firm location
Indianapolis, IN, United States

Product description

cobas p 612 pre-analytical system; Pre-analytical sample handling that includes de-capping, Aliquotting and sorting of samples for analysis.

Data sourced from openFDA. This site is unofficial and independent of the FDA.