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U.S. Department of Health and Human Services

Class 2 Device Recall COBAS INTEGRA 800 Analyzer

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  Class 2 Device Recall COBAS INTEGRA 800 Analyzer see related information
Date Initiated by Firm September 16, 2013
Date Posted November 05, 2013
Recall Status1 Terminated 3 on May 12, 2015
Recall Number Z-0168-2014
Recall Event ID 66239
510(K)Number K951595  
Product Classification Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
Product COBAS INTEGRA 800 Analyzer with software 9864.C2
Cobas. COBAS Part Numbers 28122474001, 28122474692, 04559126001, 04589459970 corresponding to the Analyzer with or without closed tube sampling accessory

A fully automated system for clinical chemistry analysis intended for the in vitro quantitative/qualitative determination of analytes in body fluids.
Code Information software version 9864.C2
Recalling Firm/
Manufacturer		 Roche Diagnostics Operations, Inc.
9115 Hague Rd
Indianapolis IN 46256-1025
For Additional Information Contact Todd Siesky
317-576-3911
Manufacturer Reason
for Recall		 Roche COBAS INTEGRA 800 system, Software Version 9864.C2 does not perform necessary ISE Service Actions. Whenever the ISE rack is removed, the ISE counters in the software are reset to zero and the corresponding Service Actions are not conducted automatically by the system. Additionally, certain maintenance activities that have to be performed manually by the operator are not requested on the sof
FDA Determined
Cause 2		 Software Design Change
Action Roche sent an Urgent Medical Device Correction letter dated September 16, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Roche Diagnostics recommends tracking all ISE counters and manually requesting the corresponding Service Actions listed in the notification be monitored until updated software becomes available during Q4 2013. If the affected product was moved to another site, the notification is to be forwarded. consignees were asked to complete the attached faxback form and fax it to 1-877-266-0997 and file the Urgent Medical Device Correction (UMDC) for future reference. Question should be directed to Roche Support Network Customer Support Center 24 hours a day, seven days a week at 1-800-428-2336 For questions regarding thisr ecall call 317-576-3911.
Quantity in Commerce 527 units
Distribution Nationwide Distribution and Puerto Rico
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 DIAGNOSTIC SYSTEMS, INC.
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