International safety notice
Alert 2755 (Technosurveillance): Update Roche Diagnóstica Brasil Ltda.
Brazil / Anvisa · BRA · Dec 28, 2018
Key facts
| Title | Alert 2755 (Technosurveillance): Update Roche Diagnóstica Brasil Ltda. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Commercial Name: Total Bilirubin Gen.3; Technical Name: BILIRUBIN; ANVISA registration number: 10287411018; Risk Class: II Affected model: N/A Affected serial numbers: See attachment "Updated list of lots at risk" Updated information: 1- List of lots at risk. |
| 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 | 10287410295, LACT2, GEN.2, 10287410361, 10287410573, 10287410127, 10287411018, Gen.3 |
| Date | Dec 28, 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