International safety notice
Technical name: Immunohistochemistry - Complementary Reagents
Brazil / Anvisa · BRA · Jan 15, 2018
Key facts
| Title | Technical name: Immunohistochemistry - Complementary Reagents |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Nome comercial: OptiView DAB IHC Detection Kit; Ultraview Universal DAB Detection Kit; OptiView Amplification Kit e Hematoxylin II Technical name: Immunohistochemistry - Complementary Reagents ANVISA registration number: 10287410832 Risk class: I Affected model: N/A. Affected serial numbers: > > Affected Lots Distributed by Roche Diagnóstica Brasil: OptiView DAB IHC Detection Kit = Lote Y11625 ultraView Universal DAB Detection Kit = Y09284 OptiView Amplification Kit = Lote Y15435 Hematoxylin II = Lote Y13938 > > Affected Lots in Stock at Roche Disgnóstica Brasil: OptiView DAB IHC Detection Kit = Lotes Y11625; Y15571; Y19271 ultraView Universal DAB Detection Kit = Lotes Y09284; Y11687; Y15384; Y17984; Y18099 OptiView Amplification Kit = Lote Y15435 Hematoxylin II = Lotes Y13938; Y17402; Y17403 NOTE: At the origin (manufacturer) there are other materials and batches affected, but which have not been imported into Brazil to date. |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO ROCHE DIAGNÓSTICA BRASIL LTDA CNPJ 30280358000186 AVENIDA ENGENHEIRO BILLINGS 1729 PRÉDIO 38 SÃO PAULO SP FABRICANTE VENTANA MEDICAL SYSTEMS INC 1910 E INNOVATION PARK DRIVE TUCSON ARIZONA 85755 USA EMAIL BRASILTECNOVIGILANCIAROCHECOM |
| Models | Y18099, Y19271, Y15384, Y11625, Y09284, Y15435, Y17402, Y11687, Y17403, Y15571, 10287410832, Y13938 and 1 more |
| Date | Jan 15, 2018 |
| 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