cobas e 801 immunoassay analyzer

On March 15, 2019, the firm notified affected customers of the recall via an Urgent Medical Device Correction letter. Customers were informed of the potential problem of signal drops when the standby bottle flowpath is covered with a biofilm. Customers were asked to do the following: " Follow the Workaround section to determine if your cobas e 801 module is potentially affected and perform the steps if applicable. " If your cobas e 801 module is potentially affected based on the information in the Workaround section of this UMDC, contact the Roche Support Network Customer Support Center at 1-800-428-2336 to schedule the ProCell II M flowpath decontamination procedure. The ProCell II M flowpath decontamination procedure should be performed every 4 weeks until your cobas e 801 module is switched to the improved ProCell II M formulation. " Identify and retest potentially affected patient samples using the Retrospectively Identify and Correct Potentially Affected Patient Sample Results section of this UMDC. " Complete the attached fax form and fax it to 1-833-254-2597 or email it to roche10068@stericycle.com.