FDAJuly 16, 2018device
Roche cobas p 612 pre-analytical system (63x) Model: 07563116001 The cobas p 612 pre-analytical system is a computer controlled fully automatic system for sorting of open and closed barcoded and centrifuged and non-centrifuged sample tubes. The cobas p 612 is intended for use with analyzers that ...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Sample material may potentially come in contact with the pipetting nozzle during operation of cobas p 612 pre-analytical system (63x) (LCP1) with non-filter tips. The possible presence of biological material on the nozzle may cause contamination resulting in potential false positive results, depending on the sensitivity of the analytical technology.
What to do
FDA enforcement status: Terminated
Brands named
roche diagnosticsroche
UPCs
07563116001
Recall history
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