Roche Diagnostics Operations, Inc. recalls Bulk Loader Module for cobas p 512/612 Pre-analytical sample handling that includes de-capping, aliquoting and sorting…

Recall date

September 22, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0297-2016

FDA classification

Class II

Brand / firm

Roche Diagnostics Operations, Inc.

Sold / distributed

Distributed to TX only.

Why it was recalled

Possible for sample tubes in the loader to be opened and contaminate the system as well as adjacent samples during processing.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.