International safety notice
Alert 2660 (Technosurveillance) - Roche Diagnóstica Brasil Ltda.
Brazil / Anvisa · BRA · Aug 30, 2018
Key facts
| Title | Alert 2660 (Technosurveillance) - Roche Diagnóstica Brasil Ltda. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade Name: Family of Complementary Reagents (Detection) Technical Name: Immunohistochemistry - Complementary Reagents ANVISA registration number: 10287410832 Risk Class: I Modelo afetado: OptiView DAB IHC Detection Kit, ultraView Universal DAB Detection Kit, CINtec PLUS Cytology Kit (CE-IVD), OptiView Amplification Kit, ultraView SISH DNP Detection Kit, Hematoxylin II, ISH iVIEW Blue Plus Detection Kit, ultraView Universal Alkaline Phosphatase Red Detection Kit, ISH Protease 3, VENTANA ISH iView Blue Detection Kit e INFORM HPV III Family 16 Probe (B) Números de série afetados: OptiView DAB IHC Detection Kit = lotes E00119, Y19271,Y11625, Y15571 | ultraView Universal DAB Detection Kit = lotes Y25695, Y09284, Y18099, Y11687, Y17984, Y19302, Y18069 | CINtec PLUS Cytology Kit (CE-IVD) = lote Y18107 | OptiView Amplification Kit = lotes Y15435, Y19322 | ultraView SISH DNP Detection Kit = lote Y26299 | Hematoxylin II = lotes Y13938, Y17402 | ISH iVIEW Blue Plus Detection Kit = lotes Y15410, Y24365 | ultraView Universal Alkaline Phosphatase Red Detection Kit = lotes Y15071, Y18053, Y22469 | ISH Protease 3 = lotes Y13927, Y18872, Y22569, Y25883 | VENTANA ISH iView Blue Detection Kit = lote Y15105 | INFORM HPV III Family 16 Probe (B) = lote Y19417 |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO ROCHE DIAGNÓSTICA BRASIL LTDA CNPJ 30280358000186 AVENIDA ENGENHEIRO BILLINGS 1729 PRÉDIO 38 SÃO PAULO SP TEL 11 37198464 EMAIL BRASILTECNOVIGILANCIAROCHECOM FABRICANTE DO PRODUTO VENTANA MEDICAL SYSTEMS INC 1910 E INNOVATION PARK DRIVE TUCSON ARIZONA 85755 USA EUA |
| Models | Y15571, Y15435, Y11687, Y19322, Y19302, Y18099, Y18107, Y19271, Y22569, Y15410, Y18872, Y18053 and 17 more |
| Date | Aug 30, 2018 |
| 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