Class 2 Device Recall cobas c513 Analyzer

• Date Initiated by Firm: July 18, 2019
• Create Date: September 05, 2019
• Recall Status: Terminated 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
• FEI Number: 1823260
• 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: 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