Events

Safety Alert for NHL, Ammonia - Registry 10287410128; NH3L - Registration 10287410768; GLDH-Glutamate Dehydrogenase - Registration 10287410752; CKMBL CK MB C111 Registration - 10287410673; CKMBL, Creatinine Kinase-MB - Registration 10287410530; CK-MB - Registration 10287410214; ASTLP, Aspartate aminotransferases acc. IFCC with pyroxidal phosphate activation - Record 10287410571; ASTL, Aspartate Aminotransferase acc. IFCC without pyroxidal phosphate activation - Record 10287410316; AST (ASAT / GOT) IFCC - Registration 10287410203; AST (ASAT / GOT) IFCC (SYS) - Registration 10287410258; ALTL, Alanine Aminotransferase acc. IFCC without phosphate activation - Record 10287410315; ALT (ALAT / GPT) IFCC (SYS) - Registration 10287410265; ALT (ALAT / GPT) IFCC - Registration 10287410184 - Lots and presentations - Annex I

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
    1633
  • Date
    2015-07-02
  • 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
    Sulfasalazine and Sulfapiridine may lead to potentially poor / high ALT, AST, CK-MB, GLDH, and NH3 testing in NAD (H) or NADP (H) ) in the reaction, which may lead to a delay in the decision of the medical evaluation.
  • Reason
    Roche diagnostics gmbh, a legal manufacturer of the products involved in this alert, made changes to the session of interfering with the use of nad (h) or nadp (h) tests (alt, ast, ck-mb, gldh and nh3), warning of possible drug interference of sulfasalazine and sulfapyridine. these changes were made in 2014.
  • Action
    At therapeutic concentrations, Sulfasalazine and Sulfapiridine may lead to potentially inadequate low / high ALT, AST, CK-MB, GLDH and NH3 tests in NAD (H) or NADP ( H) in the reaction; The abovementioned test results may be inadequately low / high when the blood sample is collected in the presence of Sulfasalazine and Sulfapyridine in the patient's blood. • Physicians should be advised that patients currently receiving Sulfasalazine and Sulfapiridine may receive possible false results of ALT, AST, CK-MB, GLDH, and NH3. Further information - Annex II Letter to the Client and Annex III List of Customers

Device

NHL, Ammonia - Registry 10287410128; NH3L - Registration 10287410768; GLDH-Glutamate Dehydrogenas...

Manufacturer

Roche Diagnóstica Brasil Ltda.; Roche Diagnostics GmBH