Class 2 Device Recall Cobas e 801

• Date Initiated by Firm: March 15, 2019
• Create Date: May 02, 2019
• Recall Status: Terminated on April 23, 2020
• Recall Number: Z-1249-2019
• Recall Event ID: 82394
• 510(K)Number: K100853 K162606 K163569
• Product Classification: Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
• Product: cobas e 801 immunoassay analyzer
• Code Information: All units may experience this issue.
• Recalling Firm/ Manufacturer: Roche Diagnostics Corporation; 9115 Hague Rd; Indianapolis IN 46256-1025
• For Additional Information Contact: 317-5214343
• Manufacturer Reason for Recall: The firm has confirmed complaints regarding signal drops on the cobas e 801 module after a ProCell II M bottle changeover, which may lead to incorrect medical decisions with respect to diagnostics and patient treatment.
• FDA Determined Cause: Device Design
• Action: 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.
• Quantity in Commerce: 149
• Distribution: Distributed to accounts in AL AZ CA CT FL HI IA IL IN KY LA MA MD ME MI MN MO NC NH NJ NY OH OR PA PR SC TN TX VA WA WI
• 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; 510(K)s with Product Code = JJE