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Recall Observatory FDA recall evidence

Device product

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

Z-1090-2017

December 27, 2016

Class II

Product summary

Firm
Roche Diagnostics Corporation
Event
Event 76078
Status
Terminated
Classification
Class II
Quantity
5
Official record key
device-enforcement:Z-1090-2017

Official wording

Reason: Unavailable

Code information: Serial Number 63004316 63004416 63004516 63002816 63002916

Distribution pattern: TX and WA