Recall Z-0297-2016
Roche Diagnostics Operations, Inc. · initiated September 22, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: 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.
Reason for recall
Possible for sample tubes in the loader to be opened and contaminate the system as well as adjacent samples during processing.
FDA-determined cause: Device Design
Action taken
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.
Details
- Recall number
- Z-0297-2016
- Initiated
- September 22, 2015
- Posted by FDA
- November 18, 2015
- Terminated
- February 3, 2016
- Product code
- JQP – Calculator/Data Processing Module, For Clinical Use
- Quantity
- 1
- Distribution
- Distributed to TX only.
- Recalling firm
- Roche Diagnostics Operations, Inc., Indianapolis, IN