International safety notice
TECHNICAL NAME: BETA HUMAN CHORIONIC GONADOTROPHIN (BHCG)
Brazil / Anvisa · BRA · Mar 21, 2016
Key facts
| Title | TECHNICAL NAME: BETA HUMAN CHORIONIC GONADOTROPHIN (BHCG) |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Affected products: Product VITROS® Immunodiagnostic Reagent Kit for β-hCG II Total --Registration no. VITROS® Immunodiagnostic Calibrators for β-hCG II Total --Registration nº.80145901051 --> Code 6802221 --> Lots 1410, 1420, 1430, 1440, 1450, 1460, 147 --> Class II |
| Manufacturer | DETENTOR DO REGISTRO NO BRASIL JOHNSON JOHNSON DO BRASIL INDÚSTRIA E COMÉRCIO DE PRODUTOS PARA SAÚDE LTDA CNPJ 54516661000101 ENDEREÇO RUA GERIVATIBA Nº 207 12º AO 15º ANDARES BUTANTÃ SÃO PAULO TELEFONE 12 3932 1963 FABRICANTE NOME ORTHO CLINICAL DIAGNOSTICS INC ENDEREÇO 1HIGH WYCOMBE FP12 4DP E 2PENCOED BRIDGEN CF35 5PZ PAÍS REINO UNIDO |
| Models | 6802220, 6802221, 80145901052, nº.80145901051 |
| Date | Mar 21, 2016 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
- 1–9 Matching device models 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