Events

Safety Alert for EliA CCP Well, EliA CCP Well, EliA CCP Well, EliA CCP Well, EliA IgG Conjugate, EliA IgG Conjugate 50, EliA IgG Conjugate 200, EliA CCP Positive Control 250, EliA CCP Positive Control 100 Conjugate 200, EliA CCP Positive Control 250, EliA CCP Positive Control 100 ANVISA Registration Number: 80254180068 Hazard Class: II Model Affected: 14-5515-01 (80254180068); 83-1005-01 (80254180059); 83-1017-01 (80254180067); 83-1018-01 (80254180128); 83-1035-01 (80254180113); 83-1040-01 (80254180116)

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Phadia Diagnosticos Ltda.; Phadia AB.

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
    2192
  • Date
    2016-10-21
  • 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
    Use the listed ranges set for EliA CCP Positive Control (83-1040-01 and 83-1035-01) when used in combination with listed batches of the indicated batches of EliA IgG Conjugate (83-1017-01, 83-1005 -01 or 83-1018-01). Do not use lots (14-5515-01 kit lot starting with 0200) from the new EliA CCP Well with lots of the EliA IgG Conjugates Antiquity listed in the Notice. Do not use lots (14-5515-01 kit lot starting with 0200) from the new EliA CCP Well with lots of EliA CCP positive controls listed in the Notification. Fill in the EliA CCP Positive Control Field Action Confirmation form on the notification and return to the record holder.
  • Reason
    The investigation of complaints received concluded that when elia ccp well (14-5515-01) is used in combination with the elia igg conjugate (83-1017-01, 83-1005-01 or 83-1018-01), the results of anti-ccp can be elevated. the positive trend of the elia ccp test will change a small percentage of test results from negative to indeterminate and from undetermined or negative high to low positive. tests on clinical serum samples from patients with confirmed rheumatoid arthritis (ra), serum from healthy blood donors and other disease controls resulted in <1% of the samples having changed from negative to positive, according to the current ranges of values ​​(the total study included 472 samples). the results of the evaluation study performed confirmed the variance within the current clinical performance, and it was concluded that the clinical impact of the observed trend can be neglected.
  • Action
    Field Action FSN Code 2016-02 triggered under the responsibility of the company PHADIA DIAGNOSTICOS LTDA. Company will guide the combination of lots of EliA CCP test

Device

EliA CCP Well, EliA CCP Well, EliA CCP Well, EliA CCP Well, EliA IgG Conjugate, EliA IgG Conjugat...

Manufacturer

Phadia Diagnosticos Ltda.; Phadia AB