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Roche Diagnostics Operations, Inc. recalls Bulk Loader Module for cobas p 512/612 Pre-analytical sample handling that includes de-capping, aliquoting and sorting
Recalled November 25, 2015 · FDA recall Z-0297-2016 · Roche Diagnostics Operations
Hazard
Possible for sample tubes in the loader to be opened and contaminate the system as well as adjacent samples during processing. · FDA Class II
Units
1
Sold at
Distributed to TX only.
Description
Possible for sample tubes in the loader to be opened and contaminate the system as well as adjacent samples during processing.
Product
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.
Manufacturer(s)
Roche Diagnostics Operations, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →