International safety notice
Alert 2754 (Technovigilance) - Roche Diagnóstica Brasil Ltda - Cobas Integra Cleaner Cassette - Clean - Need to add carryover washing for several tests on the COBAS INTEGRA 400 plus and cobas c 111 analyzers.
Brazil / Anvisa · BRA · Dec 28, 2018
Key facts
| Title | Alert 2754 (Technovigilance) - Roche Diagnóstica Brasil Ltda - Cobas Integra Cleaner Cassette - Clean - Need to add carryover washing for several tests on the COBAS INTEGRA 400 plus and cobas c 111 analyzers. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade Name: Cobas Integra Cleaner Cassette / Clean Technical Name: Equipment cleaning solution ANVISA registration number: 10287410823 / 10287411202 Risk Class: I Affected model: N/A Affected serial numbers: Cobas Integra Cleaner Cassette (Code: 20764337322 and Registration: 10287410823): 11547901; |
| 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 | 19741601, 20764337322, 16150101, 04774248190, 10287411202, 37255901, 26993001, 29358401, 20472401, 13955501, 24480801, 14195001 and 16 more |
| Date | Dec 28, 2018 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
- 1–9 Matching device models in FDA data
- 1–9 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