International safety notice
Alert 2802 (Technovigilance) - Kovalent do Brasil Ltda - alpha 1 - Acid Glycoprotein Incompatibility, in a specific batch, of the alpha1-Acid Glycoprotein standard with the Multiparametric Protein Control.
Brazil / Anvisa · BRA · Mar 7, 2019
Key facts
| Title | Alert 2802 (Technovigilance) - Kovalent do Brasil Ltda - alpha 1 - Acid Glycoprotein Incompatibility, in a specific batch, of the alpha1-Acid Glycoprotein standard with the Multiparametric Protein Control. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade Name: alpha 1 - Acid Glycoprotein Technical Name: Alpha 1-Acid Glycoprotein (AGPA) ANVISA registration number: 80115310074 Risk Class: II Affected model: 2 x 25 ml R + 1 x 1 ml Standard Affected serial numbers: 1076691873 |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO KOVALENT DO BRASIL LTDA CNPJ 04842199000156 RUA CRISTÓVÃO SARDINHA 110 JARDIM BOM RETIRO SÃO GONÇALO RJ TEL 2139072534 EMAIL REGULATORIOSBIOSYSCOMBR FABRICANTE DO PRODUTO KOVALENT DO BRASIL RUA CRISTÓVÃO SARDINHA 110 BRASIL |
| Models | 1076691873, 80115310074, 1-Glicoproteína |
| Date | Mar 7, 2019 |
| 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