Events

Safety Alert for ADVIA Chemistry ALP (AMP) Reagents - Registration No. 10345160518. Lots: R1: 7X38mL - R2: 7X11,7mL (7 x 357 tests); R1: 4X38 mL-R2: 3X15mL (4 x 350 tests). Lots: 327460

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Siemens Healthcare Diagnósticos S.A..

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
    1701
  • Date
    2015-10-21
  • 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
    Siemens has identified that the increase in the incidence of absorbance flags associated with lots of reagents is not related to inaccurate results. If results of calibrations and quality controls are acceptable, reported patient outcomes are also acceptable.
  • Reason
    Siemens healthcare has confirmed that the alkaline phosphatase reagents contained in the portuguese letter chc 15-16 (alert message) used in the advia chemistry 1200, 1800, 2400 and xpt systems have shown an increase in the incidence of flags (u and u) and errors // //. the absorbance flags u and u indicate high absorbance, exceeding the boundary values ​​defined in the test protocol for blank or sample limits. the absorbance flags //// indicate an error in the calculation, not allowing the generation of results by the system.
  • Action
    Siemens Healthcare recommends the following actions: - Discontinue use and discard batches of reagents identified in this Field Action; - Keep the Portuguese Letter CHC 15-16 (Alert Message) in your laboratory records for any future consultations.

Device

ADVIA Chemistry ALP (AMP) Reagents - Registration No. 10345160518. Lots: R1: 7X38mL - R2: 7X11,7m...

Manufacturer

Siemens Healthcare Diagnósticos S.A.
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    ANVSANVISA