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U.S. Department of Health and Human Services

Class 2 Device Recall cobas 8000 Modular Analyzer Series, Modular e602 Immunoassay Analyzer

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  Class 2 Device Recall cobas 8000 Modular Analyzer Series, Modular e602 Immunoassay Analyzer see related information
Date Initiated by Firm July 15, 2016
Create Date October 25, 2016
Recall Status1 Terminated 3 on June 05, 2017
Recall Number Z-0097-2017
Recall Event ID 75186
510(K)Number K100853  
Product Classification Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
Product cobas 8000 Modular Analyzer Series
c8000, Chemistry (Photometric, Discrete) for clinical use Modular e602: Immunoassay Analyzer

Product Usage:
The VS II system is a stand-alone, computer-controlled instrument designed to aliquot patient sample from a primary tube to a barcoded secondary tube for processing on an off-line analyzer.
Code Information Not applicable
Recalling Firm/
Manufacturer		 Roche Diagnostics Operations, Inc.
9115 Hague Rd
Indianapolis IN 46256-1025
For Additional Information Contact Roche Support Network Customer Support C
800-428-2336
Manufacturer Reason
for Recall		 Roche has received four reports of injury caused by the sharp edge of the center guide rail of an analyzers sample rack tray. The cleaning procedure for the sample rack tray has been revised to clarify the cleaning process.
FDA Determined
Cause 2		 Device Design
Action On 7/15/2016, URGENT MEDICAL DEVICE CORRECTION notifications were sent to the affected customers via courier. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, an updated cleaning procedure, and instructions for responding to the formal recall notification. Please contact the Roche Support Network Customer Support Center at 1-800-428-2336 if you have questions about the information contained in this UMDC. On 10/5/2016, URGENT MEDICAL DEVICE CORRECTION UPDATE notifications were sent to the affected customers via courier. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. The notification updated the 7/15/16 notification to include additional affected systems and to provide updated cleaning instructions for all systems via the enclosed Operators Manual addendum.
Quantity in Commerce 9014 in total
Distribution US Nationwide Distribution
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.
510(K) Database 510(K)s with Product Code = JJE and Original Applicant = ROCHE DIAGNOSTICS CORP.
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