Events

Field Safety Notices about RapidQC Complete

According to ALIMS (Agencija za lekove i medicinska sredstva), this field safety notices involved a device in Serbia that was produced by Siemens Healthcare Diagnostics Inc.

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
  • Event Date Posted
    2014-08-14
  • Event Country
    Serbia
  • Event Source
    ALIMSA
  • Event Source URL
    https://www.alims.gov.rs/latin/2014/08/14/vazno-obavestenje-o-medicinskom-sredstvu-rapidqc-complete-tip-level-1-level-2-level-3-klinicka-hemija-ostale-kontrole-level-2-lot-broj-362303/
  • Notes / Alerts
    Serbian data is current through February 2018. All of the data comes from ALIMS (Agencija za lekove i medicinska sredstva), 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 Serbia.
  • Extra notes in the data
  • Reason
    Siemens healthcare diagnostics has detected an error in expected value graphs related to level 2 ph control range for siemens gas instruments, namely rapidpoint® 400/405/500 systems, rapidlab® 1200 series systems, rapidlab 248/348 / 348ex systems, rapidlab 800 series systems and rapidpoint 340/350 systems. due to this error, the ph recovery value for rapidqc complete, level 2, lot number 362303, is elevated on all siemens gas systems. it is also possible that some instruments, at times, have a ph recovery beyond the upper range. however, the published target ranges for all other analytes are unchanged.

Device

RapidQC Complete

Manufacturer

Siemens Healthcare Diagnostics Inc
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    ALIMSA