International safety notice
Alert 1596 Updated (Technosurveillance) - Glucose meters with GDH-PQQ and glucose oxidase technologies: Risk of incorrect diagnosis in patients with galactosemia.
Brazil / Anvisa · BRA · Jun 2, 2015
Key facts
| Title | Alert 1596 Updated (Technosurveillance) - Glucose meters with GDH-PQQ and glucose oxidase technologies: Risk of incorrect diagnosis in patients with galactosemia. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Product: non-specific systems for glucose - devices for measuring and reagent strips for Glucose Dehydrogenase with Pyrroloquinone Quinone (GDH-PQQ) or mut. Access the full content of Alert 1596 with the respective annexes on the ANVISA Portal (http://portal.anvisa.gov.br/alertas). Manufacturer: All manufacturers that produce Glucose Dehydrogenase reagent strips with Pyrroloquinoline Quinone (GDH-PQQ), or mutant variations of this enzyme that also present low selectivity for sugars other than glucose (mut. Q-GDH), or that use technology based on glucose oxidase. |
| Manufacturer | FABRICANTE TODOS OS FABRICANTES QUE PRODUZIREM AS FITAS REAGENTES DE GLICOSE DESIDROGENASE COM PIRROLOQUINOLINA QUINONA GDHPQQ OU VARIAÇÕES MUTANTES DESTA ENZIMA QUE TAMBÉM APRESENTEM BAIXA SELETIVIDADE PARA AÇÚCARES QUE NÃO A GLICOSE MUT QGDH OU QUE UTILIZAM TECNOLOGIA BASEADA EM GLICOSE OXIDASE |
| Date | Jun 2, 2015 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
- 1–9 Matching catalog numbers in FDA data
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About International device safety notices
Field safety notices, recalls and safety alerts published by about 30 national medical device regulators outside the United States, matched by Orca1 to FDA device data.
Source: National medical device regulators (as listed), compiled by Orca1