Events

Recall of ADVIA CENTAUR CP SYSTEM - TSH3-ULTRA (TSH3-UL) ASSAY

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

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
    65593
  • Event Risk Class
    III
  • Event Initiated Date
    2017-12-21
  • 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
    The advia centaur cp xp and xpt systems will not expire the multi-diluent 15 pack at the end of the required 7-day on board stability (obs) if any of the affected bnp or tsh3ul lots are present on the system(s) when performing onboard dilutions. on the advia centaur xpt only the system becomes inoperable under certain specific conditions.

Device

ADVIA CENTAUR CP SYSTEM - TSH3-ULTRA (TSH3-UL) ASSAY
  • Model / Serial
    Model Catalog: 06491080 (Lot serial: KIT LOTS ENDING: 298 & 301); Model Catalog: 06491072 (Lot serial: KIT LOTS ENDING: 298 & 301); Model Catalog: 02816138 (Lot serial: KIT LOTS ENDING: 192 193 196); Model Catalog: 02816634 (Lot serial: KIT LOTS ENDING: 192 193 196)
  • Product Description
    ADVIA CENTAUR CP SYSTEM - TSH3-ULTRA (TSH3-UL) ASSAY;ADVIA CENTAUR SYSTEM - TSH3-ULTRA (TSH3-UL) ASSAY;ADVIA CENTAUR CP SYSTEM - B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAY;ADVIA CENTAUR SYSTEM - B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAY
  • Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.

Manufacturer

SIEMENS HEALTHCARE DIAGNOSTICS INC.
  • Manufacturer Address
    TARRYTOWN
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    HC