International safety notice
Alert 2901 (Technovigilance) - Diamed Latino América S.A. - Reagent for Red Blood Cells / Red Blood Cells Treated with Enzymes - DiaCell I-II Drop in reactivity for the Fyb antigen in a specific batch.
Brazil / Anvisa · BRA · Jun 10, 2019
Key facts
| Title | Alert 2901 (Technovigilance) - Diamed Latino América S.A. - Reagent for Red Blood Cells / Red Blood Cells Treated with Enzymes - DiaCell I-II Drop in reactivity for the Fyb antigen in a specific batch. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade Name: Red Blood Cells / Enzyme Treated Red Blood Cells Reagent - DiaCell I-II Technical Name: Immunohematology - Red Blood Cell Reagents / Red Blood Cells Treated with Enzymes ANVISA registration number: 80004040131 Risk Class: IV Affected model: 109792V Affected batch: 45223.70.1 |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO DIAMED LATINO AMÉRICA SA CNPJ 71015853000145 RUA ALFREDO ALBANO DA COSTA 100 DISTRITO INDUSTRIAL LAGOA SANTA MG LAGOA SANTA MG TEL 31 36899425 EMAIL BRZRABIORADCOM FABRICANTE DO PRODUTO DIAMED LATINO AMÉRICA SA RUA ALFREDO ALBANO DA COSTA 100 DISTRITO INDUSTRIAL LAGOA SANTA MG BRASIL |
| Models | 80004040131, 109792V, 45223.70.1 |
| Date | Jun 10, 2019 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
- 10–99 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