Events

Safety Alert for S2 FLUID PACK OMNI S, Registration: 10287410150, Lots: 21450781/21450887/21451391

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.

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
    1630
  • Date
    2015-07-08
  • 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 informs that when an affected S2 Fluid Pack is inserted into the cobas b 221 instrument, it will display the error message "Transponder error" and the instrument can not start the measurement until the affected S2 Fluid Pack is replaced by a packaging that does not present a defect and may lead to a delay in the measurement of the parameters. If the equipment correctly identifies the package, the measurement will proceed normally as there are no problems with the reagent.
  • Reason
    Roche diagnostics gmbh, the manufacturer of the products involved in this notification, after internal investigations identified a possible increase in the generation of transponder errors specific to s2 fluid pack reagent packs from lots 21450781, 21450887 and 21451391. such an error is detected and generated by equipment as soon as an affected s2 fluid pack is inserted, making it impossible to use it. the company informs that not all packs of fluid pack from these batches have been affected and the only way to identify whether or not the product is affected is by inserting the fluid pack fluid pack into the instrument and checking if an error message is indicated.
  • Action
    The company advises that: i) S2 Fluid Pack packages should be replaced if "Transponder error" is indicated. The affected Fluid Pack packaging must be disposed of locally. ii) In case the customer finds the message "Transponder error", we request that you contact our service center CEAC - 08007720295 for treatment of the occurrence.

Device

S2 FLUID PACK OMNI S, Registration: 10287410150, Lots: 21450781/21450887/21451391

Manufacturer

Roche Diagnóstica Brasil Ltda.; Roche Diagnostics GmBH