Alerte De Sécurité sur Diagnostic Kit IMMULITE 2000/2000 XPi GI-MA (CA 19-9), Risk Class III, Registration: 10345160776, Batches 312 and 313. All products are in stock.

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par Siemens Healthcare Diagnósticos Ltda.; Siemens Healthcare Diagnostics Products GmbH.

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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.

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  • Type d'événement
    Safety alert
  • ID de l'événement
    1543
  • Date
    2015-03-13
  • Pays de l'événement
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
  • Notes / Alertes
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 data from the U.S. and Brazil.
  • Notes supplémentaires dans les données
    Other clarifications from the company regarding the problem encountered are: - While recovery with patient samples for batches of individual kits continues to meet Siemens' quality control specifications, it has been observed that lot 311 at the lower limit and lot 312 at the upper limit of the curve, are resulting in higher than expected values ​​due to the difference between the two kits. - When comparing lot 312 with lot 311, Siemens observed a mean bias of 38% (ranging from 30% to 47%) for patient samples recovering from 29.6 to 44.4 U / mL and an average of 5% bias (range of 1% to 11%) for patient samples recovering from 540 to 660 U / mL. In future batches of kits, recovery of Quality Control and patient samples similar to lot 312 are expected. - The health risk is related to a delay in the test if the laboratories choose not to perform the test for more than one month. It is limited to a potential delay in radiographic tests if the biochemical tests indicate the recurrence of the disease. If the labs continue with the test, there may be a potential for additional radiographic examination. However, this will not lead to a health risk.
  • Cause
    Positive bias for the bio-rad lyphochek® tumor marker plus control and the bio-rad liquichek ™ tumor marker control, when used in conjunction with batches 312 and 313 of the immulite 2000 / immulite 2000 xpi gi-ma assay (ca 19 -9). the appearance of the bias was due to the introduction of a new batch of murine monoclonal antibodies to the batch 312 kit. the bio-rad lyphochek tumor marker plus and liquichek tumor marker controls were redefined for the immulite 2000 / immulite 2000 xpi gi-ma kits (ca19-9), lots 312 and above. in addition, a larger than expected change in patient sample retrieval can be observed when migration of kits lot 311 to lots 312 and above occurs.
  • Action
    According to the registry holder, if lot 311 was used, Siemens recommends considering new patient monitoring using the GI-MA IMMULITE 2000 / IMMULITE 2000 XPi kits, lots 312 and above. It is also advised to keep the letter of the Urgent Field Safety Notification along with the laboratory records. //// Review of previously released results is not recommended. //// If the patient was monitored using lot 311, consider a new monitoring using lots 312 and above. (SEE ATTACHED)

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