Events

Rappel Ou Alerte De Sécurité sur Thermometer medical maximum glass mercury (coated / uncoated) TU 944-033-402-2008

Selon Ministry of Health of the Republic of Belarus, ce/cet/cette rappel ou alerte de sécurité concerne un dispositif en/au/aux/à Belarus qui a été fabriqué par JSC "Termopribor" Klin, RUSSIA.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Recall / Safety alert
  • Numéro de l'événement
    ИМ-7.101982
  • Date
    2016-05-19
  • Pays de l'événement
    Belarus
  • Source de l'événement
    MHRB
  • URL de la source de l'événement
    https://www.rceth.by/ru/Safety/MedSafety
  • Notes / Alertes
    Belarussian data is current through June 2016. 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 Belarus.
  • Notes supplémentaires dans les données
  • Cause
    According to the certificate of expertise dated april 20, 2016, ojsc thermopribor, the main distinguishing features of the original thermometer from the counterfeit one are: 1. thermometer scale: marking on the scale of the counterfeit thermometer is printed in a larger font than in the original thermometer. on all scales of thermometers produced by odo “thermopribor” on the reverse side of the top there is a scale number. on counterfeit products - no digital scale. 2. verification mark: the mark of a counterfeit thermometer is distinguished by its type and size. the stamp of a counterfeit thermometer is applied in another way, the glass at the site of application of the stamp to the touch has a rough surface, on the original thermometers - smooth. the image of the stamp has clear boundaries, on the original "blurry". 3. case: in the original thermometer - semicircular, in counterfeit - square. a color copy of the examination certificate dated april 20, 2016 of ojsc “termopribor” is on the website of the ue “center for expertise and testing in health care” www.Rceth.By in the section “safety and quality of medical products” http://www.Rceth.By/ com / safety / medsafety. in connection with the above, in accordance with clause 8.16 of the statute on the ministry of health of the republic of belarus, approved by decree of the council of ministers of the republic of belarus of 28.10.2011 no. 1446 (as amended on 27.12.2012) “on some issues of the ministry of health and measures to implement the decree of the president of the republic of belarus dated august 11, 2011 no. 360 »the ministry of health of the republic of belarus exercises state control over the quality of medical devices and medical equipment when health facilities are available pharmacy network, business entities of non-state ownership of counterfeit products: medical thermometer maximum glass mercury (coated / uncoated) tu 944-033-402-2008, produced by termopribor klin, russia, these medical products must be returned to the supplier product and inform the ue "center for expertise and testing in health care", at: friendly 2a, minsk, 220037.

Device

Thermometer medical maximum glass mercury (coated / uncoated) TU 944-033-402-2008

Manufacturer

JSC "Termopribor" Klin, RUSSIA
  • Source
    MHRB