Events

Field Safety Notices about Cobas

According to Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), this field safety notices involved a device in Slovenia that was produced by Hitachi High Technologies Corporation.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Date
    2017-03-02
  • Event Country
    Slovenia
  • Event Source
    AMPMDRS
  • Notes / Alerts
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • Extra notes in the data
  • Reason
    We regret to inform you that in very rare cases a disturbance of the sample liquid level detection (lld) may occur due to a fretting corrosion on the sample probe connector due to a production change for the connector. in those very rare cases where the disturbance of the sample liquid level detection (lld) occurs, the affected sample probe may dip into the sample material deeper than intended, accordingly the affected sample probe may be not washed adequately (this may lead to carryover, medical risk cannot be excluded). since the beginning of 2017, the affected sample probe connector type has been changed in production to a new connector type. with that new connector type the sample liquid level detection (lld) is ensured to fully function as specified. the potentially affected sample probes will be exchanged free of charge. .

Device

Cobas
  • Model / Serial
    cobas c 311 analyzer (cat. no. 04826876001) cobas c 501 module (cat. no. 04745914001) cobas c 502 module (cat. no. 05964067001) cobas c 701 module (cat. no. 05641489001) cobas c 702 module (cat. no. 06473245001) cobas 8000 ISE module 900 (cat. no. 05641497001) cobas 8000 ISE module 1800 (cat. no. 05964075001)
  • Manufacturer
    Hitachi High Technologies Corporation

Manufacturer

Hitachi High Technologies Corporation