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U.S. Department of Health and Human Services

Class 2 Device Recall cobas e 801 module

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  Class 2 Device Recall cobas e 801 module see related information
Date Initiated by Firm April 03, 2018
Create Date June 10, 2018
Recall Status1 Terminated 3 on November 21, 2019
Recall Number Z-2136-2018
Recall Event ID 79805
510(K)Number K100853  K163569  K162606  
Product Classification Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
Product cobas e 801 immunoassay analyzer, cobas 8000 Modular Series

The device is a fully automated, software controlled analyzer system for in vitro determination of analytes in human body fluids. It is part of the cobas 8000 modular analyzer series. It uses electrochemiluminescent technology for signal generation and measurement.
Code Information Serial numbers: 1744-08 1744-09 1744-10 1758-08 1606-09 1752-05 1752-06 1630-08 1738-01 1744-07 1758-09 1759-04 1758-06 1758-07 1743-09 1743-10 1752-04 1759-05 17C5-06 17C5-07 1615-08 1612-10 17C5-09 1744-05 1744-06 1743-07 1743-08 1744-03 1744-04 1759-06 17C5-05 17C5-08 17C5-10 17C6-01 17C6-02 
Recalling Firm/
Roche Diagnostics Corporation
9115 Hague Rd
Indianapolis IN 46256-1025
For Additional Information Contact
Manufacturer Reason
for Recall
The syringe plunger on the device may be mounted in a tilted position, which applies mechanical stress to the plunger. In the worst case scenario, the plunger may crack leading to impaired syringe function.
FDA Determined
Cause 2
Process design
Action On April 3, 2018, The Firm sent an Urgent Medical Device Correction letter via UPS Ground. Consignees were notified of the possible failure. Consignees were informed that a Roche representative would contact them to install a syringe plunger guide for the affected syringes to resolve the issue. In the meantime, consignees were instructed to only measure assays that do not require prewash steps and assays that are not impacted by missing prewash step until the syringe plunger guide is installed on the affected module. If the customer identifies broken syringe plungers on their device, the notice instructed them to contact the Roche Support Network Customer Support Center at 1-800-428-2336, available 24 hours a day, 7 days a week. Customers were asked to complete a customer response form and return it to the firm.
Quantity in Commerce 35
Distribution US Distribution to the states of : CA, CT, IA, IN, KY, ME, MI, NC, NY, OH, SC, TX, and VA.
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
510(K)s with Product Code = JJE and Original Applicant = ROCHE DIAGNOSTICS CORP.