International safety notice
Alert 2955 (Technovigilance) UPDATE - Roche Diagnóstica Brasil Ltda - Elecsys Anti-CCP - Falsely high results for all batches in plasma samples and removal of the use of plasma as a sample type.
Brazil / Anvisa · BRA · Aug 20, 2019
Key facts
| Title | Alert 2955 (Technovigilance) UPDATE - Roche Diagnóstica Brasil Ltda - Elecsys Anti-CCP - Falsely high results for all batches in plasma samples and removal of the use of plasma as a sample type. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Nome Comercial: Elecsys Anti-CCP. Technical Name: Anti-Cyclic Citrullinated Peptide (ANTI-CCP). ANVISA registration number: 10287410828. Product type: Diagnostic product for in vitro use. Risk Class: II. Affected model: 100 tests. Affected serial numbers: all current batches and future batches. Access the full content of Alert 2955 with the respective annexes on the ANVISA Portal (http://portal.anvisa.gov.br/alertas). |
| 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 | 10287410828 |
| Date | Aug 20, 2019 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
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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.
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