Events

Rappel de Siemens Berichrom Protein C on Sysmex CA-1500, CA-7000, CS-2000i, CS-2100i, and CS-5100 instruments

Selon New Zealand Medicines and Medical Devices Safety Authority, ce/cet/cette rappel concerne un dispositif en/au/aux/à New Zealand qui a été fabriqué par manufacturer #1479.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    18533
  • Date de mise en oeuvre de l'événement
    2018-07-10
  • Pays de l'événement
    New Zealand
  • Source de l'événement
    NZMMDSA
  • URL de la source de l'événement
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alertes
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notes supplémentaires dans les données
    Recalling Organisation: Siemens Healthcare (NZ) Ltd, Millennium Centre, Part Level 2, Building A, 600 Great South Road, Ellerslie, AUCKLAND 1051
  • Cause
    Siemens healthcare diagnostics has confirmed that a number of lots can lead to the failure of calibration on sysmex® ca-1500, ca-7000, cs-2000i, cs-2100i, and cs-5100 instruments., in case the berichrom protein c calibration curve on the above mentioned systems is indicated as being invalid due to the 0% point of the calibration by "reaction curve error", the measurement signal does not meet the instrument's check algorithm for at least a value of 0.001dod and therefore this point gets flagged., follow-up communication, the manufacturer has issued a new protocol disc version with new and enhanced assay applications for sysmex cs-2000i/cs-2100i systems. this also includes a new protocol disc version with new and enhanced assay applications for sysmex cs-2500 systems and on sysmex cs-5100 systems.
  • Action
    Manufacturer to issue advice regarding use

Device

Siemens Berichrom Protein C on Sysmex CA-1500, CA-7000, CS-2000i, CS-2100i, and CS-5100 instruments
  • Modèle / numéro de série
    Model: Catalogue Numbers: OUVV15 & OUVV17, Affected: First affected lot: 45059 (subsequent lots with higher lot numbers might also be affected), plus 44851
  • Manufacturer
    manufacturer #1479

Manufacturer

manufacturer #1479