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U.S. Department of Health and Human Services

Class 2 Device Recall Bulk Loader Module for cobas p 512/612

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  Class 2 Device Recall Bulk Loader Module for cobas p 512/612 see related information
Date Initiated by Firm September 22, 2015
Date Posted November 18, 2015
Recall Status1 Terminated 3 on February 03, 2016
Recall Number Z-0297-2016
Recall Event ID 72427
Product Classification Calculator/data processing module, for clinical use - Product Code JQP
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.
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.
Recalling Firm/
Roche Diagnostics Operations, Inc.
9115 Hague Rd
Indianapolis IN 46256-1025
For Additional Information Contact Todd Siesky
Manufacturer 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 2
Device Design
Action 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.
Quantity in Commerce 1
Distribution Distributed to TX only.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.