International safety notice
Alert 2807 (Technovigilance) - Wama Produtos Para Laboratórios Ltda - Immuno-Rápido Syphilis - Color change in bottles of diluent solutions from specific batches.
Brazil / Anvisa · BRA · Mar 11, 2019
Key facts
| Title | Alert 2807 (Technovigilance) - Wama Produtos Para Laboratórios Ltda - Immuno-Rápido Syphilis - Color change in bottles of diluent solutions from specific batches. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade Name: Immuno-Rapid Syphilis Technical Name: Treponema Pallidum ANVISA registration number: 10310030094 Risk Class: IV Affected model: Affected serial numbers: Final Product Lots: 18C087, 18C093, 18C095, 18C215B, 18C215C, 18C216B, 18C216C, 18E102B, 18F001, 18F005, 18F009, 18F009B, 18F013, 18F017, 18F021, 18F025, 18F029, 18H023, 18H030, 18H034, 18H038 , 18h038b, 18h156, 18h160, 18h164, 18h185, 18h189, 18h193, 18h193b, 18i001, 18i005 and 18i009 affected lots of buffer 18c091, 18f029, 18h043. |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO WAMA PRODUTOS PARA LABORATÓRIOS LTDA CNPJ 66000787000108 RUA ALDO GERMANO KLEIN 100 CEAT SÃO CARLOS SP TEL 16 33779977 EMAIL RENATAWAMADIAGNOSTICACOMBR FABRICANTE DO PRODUTO WAMA PRODUTOS PARA LABORATÓRIOS LTDA RUA ALDO GERMANO KLEIN 100 CEAT BRASIL |
| Models | 18F005, 18C216C, 18I009, 18C095, 18H043, 18I005, 18F009, 18I001, 18C215B, 18C093, 18F021, 18H156 and 23 more |
| Date | Mar 11, 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