International safety notice
Alert 1373 (Technovigilance) - Qiagen Biotecnologia Brasil LTDA.
Brazil / Anvisa · BRA · Jul 5, 2021
Key facts
| Title | Alert 1373 (Technovigilance) - Qiagen Biotecnologia Brasil LTDA. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Commercial Name: therascreen PIK3CA RGQ PCR kit RUO (Note: There is an MDx version [Therascreen PIK3CA RGQ PCR Kit] - registered with ANVISA - Reg. No. 10322250098 [DOU 11/30/2020], however the MDx version was never commercialized in Brazil) Technical Name: therascreen PIK3CA RGQ PCR kit - REF 873101. ANVISA registration number: 10322250098. Product type: XXX Risk Class: Class III: products with high risk to the individual and/or medium risk to public health Affected model: XXX Affected serial numbers: PIK3CA RGQ PCR Kit, REF 873101 - Note: There is an MDx version [Therascreen PIK3CA RGQ PCR Kit, REF 873111] - registered with ANVISA - Reg. No. 10322250098 [DOU 11/30/2020], however, To date, the MDx version has never been sold in Brazil. |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO QUIAGEN BIOTECNOLOGIA BRASIL LTDA CNPJ 01334250000120 AVENIDA DO CAFÉ 277 BLOCO A CONJUNTO 202 VILA GUARANI SÃO PAULO SÃO PAULO TEL 55 11 50794083 EMAIL MAURARIBEIROQIAGENCOM FABRICANTE DO PRODUTO QIAGEN GMBH QIAGEN STRASSE 1 40724 HILDEN ALEMANHA |
| Models | 873111, 873101, 10322250098, PIK3CA |
| Date | Jul 5, 2021 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
- 1–9 Matching device models in FDA data
- 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