Events

Recall of COBAS 4000 - COBAS C 311 (STAND ALONE CONFIGURATION)

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by ROCHE DIAGNOSTICS.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    116772
  • Event Risk Class
    II
  • Event Initiated Date
    2017-03-03
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    Following a production change of connector types for the sample probe plug it was confirmed by the manufacturer that in very rare cases a disturbance of the sample liquid level detection (lld) may occur. this may cause the affected sample probe to dip into the sample material deeper than intended causing the affected sample probe to be washed inadequately and lead to a potential carryover.

Device

COBAS 4000 - COBAS C 311 (STAND ALONE CONFIGURATION)
  • Model / Serial
    Model Catalog: 04826876001 (Lot serial: 16F9-20); Model Catalog: 04826876001 (Lot serial: 16F9-10 to 16F9-18); Model Catalog: 04826876001 (Lot serial: 15D0-01 to 16D8-20); Model Catalog: 04826876001 (Lot serial: 16D9-02 to 16E0-10); Model Catalog: 06473245001 (Lot serial: 15F6-07 to 17M8-10); Model Catalog: 04826876001 (Lot serial: 16E0-16 to 16F9-08); Model Catalog: 04745914001 (Lot serial: 15P1-01 to 16Y4-19); Model Catalog: 04745914001 (Lot serial: 16Y5-01 to 17Z3-20); Model Catalog: 05641489001 (Lot serial: 15E6-01 to 17H7-10); Model Catalog: 05964075001 (Lot serial: 17L9-10); Model Catalog: 05964067001 (Lot serial: 15A6-01 to 16D9-10); Model Catalog: 05964075001 (Lot serial: 15D5-01 to 17L8-10); Model Catalog: 05964075001 (Lot serial: 17L9-09)
  • Product Description
    COBAS 4000 - COBAS C 311;COBAS 8000-C702 CHEMISTRY ANALYZER;COBAS 6000 - C501 CHEMISTRY ANALYZER;COBAS 8000-C701 CHEMISTRY ANALYZER;ISE1800 ADDITIONAL MODULE FOR COBAS 8000;559756 COBAS 8000-C502 CHEMISTRY ANALYZER
  • Manufacturer
    ROCHE DIAGNOSTICS

Manufacturer

ROCHE DIAGNOSTICS
  • Manufacturer Address
    LAVAL
  • Manufacturer Parent Company (2017)
    Roche Holding AG
  • Source
    HC