International safety notice
Alert 2816 (Technosurveillance) Update Orangelife Action HIV Self-Test Recall of two specific lots determined by RE nº 565, of 02/28/2019, and expansion of the action to new lots.
Brazil / Anvisa · BRA · Mar 14, 2019
Key facts
| Title | Alert 2816 (Technosurveillance) Update Orangelife Action HIV Self-Test Recall of two specific lots determined by RE nº 565, of 02/28/2019, and expansion of the action to new lots. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Commercial Name: Action Technical Name: Self-test for Human Immunodeficiency Virus (HIV) Antibodies ANVISA registration number: 80535240050 Risk Class: IV Affected presentation: Kit for 1 test Affected serial numbers: 183AHI1023UK; |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO ORANGELIFE COMÉRCIO E INDÚSTRIA CNPJ 09449181000102 ESTRADA DOS BANDEIRANTES 11742 PARTE VARGEM PEQUENA RIO DE JANEIRO RJ TEL 2124421121 EMAIL LARISSAORANGELIFECOMBR FABRICANTE DO PRODUTO ORANGELIFE COMÉRCIO E INDÚSTRIA LTDA ESTRADA DOS BANDEIRANTES 11742 VARGEM PEQUENA RIO DE JANEIRORJ BRASIL |
| Models | 183AHI1028UK, 183AHI1025UK, 183AHI1032UK, 183AHI1031UK, 183AHI1023UK, 183AHI1033UK, 183AHI1038UK, 183AHI1027UK, 183AHI1029UK, 183AHI1039UK, 183AHI1037UK, 183AHI1036UK and 6 more |
| Date | Mar 14, 2019 |
| Regulator page | anvisa.gov.br |
At a glance
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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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