Recall Z-0297-2016— Roche Diagnostics Operations, Inc.
Class II · Terminated
Class II FDA medical device recall by Roche Diagnostics Operations, Inc., initiated 2015-09-22, terminated 2016-02-03. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: Possible for sample tubes in the loader to be opened and contaminate the system as well as adjacent samples during processing..
- Recalling firm
- Roche Diagnostics Operations, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-09-22
- Terminated
- 2016-02-03
- Firm location
- Indianapolis, IN, United States
Product description
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.
Reason for recall
Possible for sample tubes in the loader to be opened and contaminate the system as well as adjacent samples during processing.
Data sourced from openFDA. This site is unofficial and independent of the FDA.