International safety notice
Technical Name: Vitros Immunodiagnostic Reagent for Syphilis TPA - Treponema Pallidum
Brazil / Anvisa · BRA · May 9, 2016
Key facts
| Title | Technical Name: Vitros Immunodiagnostic Reagent for Syphilis TPA - Treponema Pallidum |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Product name: Vitros Immunodiagnostic Reagent for Syphilis TPA, ANVISA Registration 80145901397. Classification IV 7,400 affected units were imported into Brazil, of which 4,300 were distributed on the Brazilian market. |
| Manufacturer | O DETENTOR DE REGISTRO DO REAGENTE IMUNODIAGNÓSTICO VITROS PARA SÍFILIS TPA É A EMPRESA JOHNSON JOHNSON DO BRASIL IND E COM DE PROD PARA SAÚDE LTDA CNPJ 54516661000101 LOCALIZADA NA RUA GERIVATIVA N 207 SÃO PAULO SP SENDO QUE O FABRICANTE DOS PRODUTOS AFETADOS É A EMPRESA ORTHO CLINICAL DIAGNOSTICS LOCALIZADA NO REINO UNIDO |
| Models | 80145901397, 2.900, 6842803, 4.300, 7.400 |
| Date | May 9, 2016 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
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