International safety notice
Alert 2983 (Technovigilance) - DiaSorin Ltda - Test Elisa Chagas III Collection Action resulting from a precautionary measure published in Resolution RE No. 2,247, of August 15, 2019.
Brazil / Anvisa · BRA · Aug 29, 2019
Key facts
| Title | Alert 2983 (Technovigilance) - DiaSorin Ltda - Test Elisa Chagas III Collection Action resulting from a precautionary measure published in Resolution RE No. 2,247, of August 15, 2019. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Commercial Name: Test Elisa Chagas III Technical name: Trypanosoma cruzi ANVISA registration number: 10339840329 Risk Class: IV Affected model: 192 tests Affected batch numbers: Lots from 02/03/2017 (1W170322; 1G180111) |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO DIASORIN LTDA CNPJ 01896764000170 AV ERMANO MARCHETTI 1435 14º ANDAR SÃO PAULO SP TEL 11 36186019 EMAIL RICARDOMONTEIRODIASORINCOMBR FABRICANTE DO PRODUTO GRUPOBIOS SA AV ZAÑARTU 1482 ÑUÑOA SANTIAGO CHILE |
| Models | 1G180111, 10339840329, 1W170322 |
| Date | Aug 29, 2019 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
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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.
Source: National medical device regulators (as listed), compiled by Orca1