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.
Recall
- Recall Number
- Z-0297-2016
- Event Number
- 72427
- Firm
- Roche Diagnostics Operations, Inc.
- FEI Number
- 1823260
- Product Code
- JQP
- Status
- Terminated
- Root Cause
- Device Design
- Initiated
- September 22, 2015
- Posted
- November 18, 2015
- Terminated
- February 3, 2016
- Address
- 9115 Hague Rd, Indianapolis, IN, 46256-1025
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.
Possible for sample tubes in the loader to be opened and contaminate the system as well as adjacent samples during processing.
Roche Diagnostics Operations, Inc. sent an Urgent Medical Device Correction letter to affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were asked to retain the Urgent Medical Device Correction letter until a Roche Field Service Representative has installed the BLM modification kit. Consignees were also asked to complete the attached form and fax to 1-877-906-8982, ext 2015. Consignees with questions were instructed to call 1-800-428-2336. For questions regarding this recall call 317-521-3911.
Distributed to TX only.
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