International safety notice
Alert 2684 (Technovigilance) - Bio-Rad Laboratórios Brasil Ltda - Pastorex Meningitis Possibility of false positive result with specific reagent for S. pneumoniae.
Brazil / Anvisa · BRA · Sep 26, 2018
Key facts
| Title | Alert 2684 (Technovigilance) - Bio-Rad Laboratórios Brasil Ltda - Pastorex Meningitis Possibility of false positive result with specific reagent for S. pneumoniae. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade Name: Pastorex Meningitis Technical Name: Combined Parameters in the same product - Class III ANVISA registration number: 80020690168 Risk Class: III Affected model: 61607 Affected serial numbers: 64160551, 64169521 |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO BIORAD LABORATÓRIOS BRASIL LTDA CNPJ 03188198000177 RUA ALFREDO ALBANO DA COSTA 100 SALAS 12 E 3 DISTRITO INDUSTRIAL LAGOA SANTA MG TEL 31 3689 9425 EMAIL BRZRABIORADCOM FABRICANTE DO PRODUTO BIORAD 3 BOULEVARD RAYMOND POINCARÉ 92430 MARNESLACOQUETTE FRANÇA |
| Models | 64169521, 80020690168, 64160551, 61607 |
| Date | Sep 26, 2018 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
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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