Recall Z-2476-2019

Reason for recall

Quality issue with high pressure solenoid valves may cause inaccurate results.

FDA-determined cause: Device Design

Action taken

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.