Z-0297-2016 Class II Terminated
FDA device recall Z-0297-2016 was initiated by Roche Diagnostics Operations, Inc. on Sep 22, 2015 and is designated Class II. Reason for recall: Possible for sample tubes in the loader to be opened and contaminate the system as well as adjacent samples during processing. The recall status is terminated (terminated Feb 3, 2016). Affected quantity: 1.
Recall Details
- Product Type
- Devices
- Report Date
- Nov 25, 2015
- Initiation Date
- Sep 22, 2015
- Termination Date
- Feb 3, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1
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.
Distribution Pattern
Distributed to TX only.
Code Information
During transport from the Bulk Loader Module (BLM), catalog number 07135645001, to the cobas p 512/p 612 pre-analytical instruments, sample tubes may inadvertently open and spill, causing contamination of the system.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0297-2016
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026