Events

Safety Alert for Homocysteine ​​Enzymatic Assay /// Registration 10287411008 /// Technical Name: Homocysteine ​​/// Risk Class: II - products of medium risk to the individual and / or low risk to public health, subject to registration /// Lots: 69781101 /; 69781401; 69780301 (SCHEDULE OF DISTRIBUTION IN ANNEX)

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Roche Diagnóstica Brasil Ltda.; Roche Diagnostics GmBH; Unomedical.

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
    1549
  • Date
    2015-04-10
  • 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
    Actions to be taken by the customer / user, according to the company: • Customers must stop using the affected product (affected batches), eliminating it locally and switching to subsequent batches of HCYS that are not affected: Batch Affected: 69780301 / 69781101/69781401 - Expiry date30 / 04/2015 - Using Subsequent Batches: 607116101/60716801/60717101 - Validity 1/31/2016
  • Reason
    The company reported that "customers complained of a 20% decrease in control levels when using non-roche controls (eg, thermofisher liqimmune) with the reagent homocysteine ​​from lot 697811 on cobas c 501 equipment. lot 604303, controls were within range. comparison of patient samples with reagent lot 697811 versus lot 604303 showed a deviation of up to 54%. plasma samples were used in edta. this negative deviation could result, in the worst case, in low homocysteine ​​results. however, it is unlikely that inaccurately low homocysteine ​​results could have caused an immediate adverse event, since homocysteine ​​has been shown to be an indicator of long-term cardiovascular risk (late cardiac events) rather than short-term events. ".
  • Action
    Company communicated its customers by letter (LETTER IN ANNEX) Type of action: Notice to Customers and Distributors not to use affected lots (LETTER IN ANNEX) /// Code: SBN_RPD_2015_006

Device

Homocysteine ​​Enzymatic Assay /// Registration 10287411008 /// Technical Name: Homocysteine ​​//...

Manufacturer

Roche Diagnóstica Brasil Ltda.; Roche Diagnostics GmBH; Unomedical