International safety notice
Alert 2857 (Technosurveillance): Update Roche Diagnóstica Brasil Ltda.
Brazil / Anvisa · BRA · Apr 25, 2019
Key facts
| Title | Alert 2857 (Technosurveillance): Update Roche Diagnóstica Brasil Ltda. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade Name: BILD2 - Bilirubin Direct Gen.2 Technical Name: Bilirubin ANVISA registration number: 10287410957 Risk Class: II Affected model: 500 tests Affected serial numbers: Product Code: 05168384190, Lot: 33798101; |
| 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 ROCHE DIAGNOSTICS GMBH SANDHOFER STRASSE 116 68305 ALEMANHA |
| Models | 35714101, 10287410957, Gen.2, 33798101, 05168384190, BILD2 |
| Date | Apr 25, 2019 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
- 10–99 Matching catalog numbers 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