Events

Safety Alert for N Latex IgM Reagent, 105 Test Kit - Record 10345161169 - Lot 44018

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Siemens Healthcare Diagnósticos Ltda.; Siemens Healthcare Diagnostics Products GmbH.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    1499
  • Date
    2015-01-21
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    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.
  • Extra notes in the data
    The company reports that the incremental risk due to the issue associated with an overestimation of the CSF serum IgM ratio was assessed as being low. Determination of IgM in CSF is not affected. The falsely increased CSF / serum IgM Ratio may lead the clinician to believe that a patient has an intrathecal IgM synthesis related to inflammation or infection of the brain, spinal cord, and meninges. This may lead to further unnecessary investigations and / or delay in treatment and may cause temporary or reversible damage.
  • Reason
    Siemens healthcare diagnostics has confirmed claims indicating a potential for falsely low igm results obtained in serum samples using the affected n latex igm batches. evaluation of intrathecal igm synthesis with n latex igm results in serum and cerebrospinal fluid (csf) samples can be obtained from a calibration curve. if an igm (igmcsf / igmsoro) quotient is calculated using a falsely low serum result and if the result is transferred to a reiber diagram, this quotient will be very high and may result in overestimation of a possible intrathecal igm synthesis.
  • Action
    Customers have been instructed to discontinue use of the product, segregate any remaining stock for Siemens to arrange for collection of these units. In addition, Siemens recommends: • If the affected batches were used to determine the IgM ratio (IgMCSF / IgMsoro) using the Reiber diagram, we recommend that you do the following: i) If the calculated IgM quotient is in the range between the range of the normal upper range and the range + 40% in the Reiber diagram (for details, see Annex - Client Letter), the result can be overestimated due to the falsely low IgM result obtained in the serum sample. ii) We recommend reconsidering the diagnosis of the respective patient considering the clinical history of the patient. iii) In case additional patient results do not support the result of an intrathecal IgM synthesis or inflammation, a re-measurement of samples may be considered using an alternative batch.

Device

N Latex IgM Reagent, 105 Test Kit - Record 10345161169 - Lot 44018

Manufacturer

Siemens Healthcare Diagnósticos Ltda.; Siemens Healthcare Diagnostics Products GmbH
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    ANVSANVISA