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U.S. Department of Health and Human Services

Class 2 Device Recall cobas c513 Analyzer

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  Class 2 Device Recall cobas c513 Analyzer see related information
Date Initiated by Firm July 18, 2019
Create Date September 05, 2019
Recall Status1 Terminated 3 on June 15, 2020
Recall Number Z-2478-2019
Recall Event ID 83525
510(K)Number K160571  
Product Classification Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
Product cobas c513 Analyzer
Code Information Serial # :1731-08, 1722-03
Recalling Firm/
Manufacturer		 Roche Diagnostics Operations, Inc.
9115 Hague Rd
Indianapolis IN 46256-1025
For Additional Information Contact Roche Support Network Customer Support Center
800-428-2336
Manufacturer Reason
for Recall		 Quality issue with high pressure solenoid valves
FDA Determined
Cause 2		 Device Design
Action 1. For the cobas¿ 8000 ISE, cobas c 701, and cobas c 702 modules and the cobas c 513 analyzer, stop using these units immediately. Your FES will be in contact with you to replace these affected high pressure solenoid valves immediately. 2. In the event that the high pressure solenoid valves cannot be replaced immediately, for the cobas e 601 module, follow the wash station checks outlined in this Urgent Medical Device Correction (UMDC). Perform these checks once per shift. If these checks show favorable outcomes and quality control results are within range, patient results may be reported. If these checks produce unfavorable outcomes, stop using your cobas e 601 module and call the Roche Support Network Customer Support Center at 1-800-428-2336. 3. Complete the attached fax form and fax or email it according to the instructions on the form. 4. File this Urgent Medical Device Correction (UMDC) for future reference Please contact the Roche Support Network Customer Support Center, 24 hours a day, seven days a week at 1-800-428-2336 if you have questions about the information contained in this UMDC.
Quantity in Commerce 2 units
Distribution State NY MT HI IN MD TX OH KS KY CA FL OR LA MO AK
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 Operations (RDO)
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