FDASeptember 22, 2015device
Bulk Loader Module for cobas p 512/612 Pre-analytical sample handling that includes de-capping, aliquoting and sorting of samples for analysis. In vitro diagnostic machine component.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Possible for sample tubes in the loader to be opened and contaminate the system as well as adjacent samples during processing.
What to do
FDA enforcement status: Terminated
Brands named
roche diagnostics operationsrocheroche diagnostics
UPCs
07135645001
Recall history
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