cobas p 612 pre-analytical system; Pre-analytical sample handling that includes de-capping, Al...
FDA Recall #Z-1090-2017 — Class II — December 27, 2016
Product Description
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 — Indianapolis, IN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
5
Distribution
TX and WA
Code Information
Serial Number 63004316 63004416 63004516 63002816 63002916
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated