International safety notice
Alert 2689 (Technovigilance) - Tecnosuma Comércio e Indústria de Kits Diagnósticos e de Equipamentos Médicos Ltda Umelisa and Umtest - Compliance with RE No. 1,723, of July 4, 2018 - Product recall.
Brazil / Anvisa · BRA · Oct 3, 2018
Key facts
| Title | Alert 2689 (Technovigilance) - Tecnosuma Comércio e Indústria de Kits Diagnósticos e de Equipamentos Médicos Ltda Umelisa and Umtest - Compliance with RE No. 1,723, of July 4, 2018 - Product recall. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Nome Comercial: Umelisa 17 OH Progesterona Neonatal; Technical Name: 17-Hydroxyprogesterone; ANVISA registration number: 10188410022; Risk Classes: II; Affected models: All product presentations listed. Affected batch numbers: All |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO TECNOSUMA COMERCIO E INDUSTRIA DE KITS DIAGNÓSTICOS E DE EQUIPAMENTOS MÉDICOS LTDA CNPJ 64779853000156 RUA TIMÓTEO 1020 SANTA INÊS BELO HORIZONTE MG TEL 3134864631 EMAIL TSMGHELOISAUOLCOMBR FABRICANTE DO PRODUTO CENTRO DE INMUNOENSAYO CALLE 134 Y AVE 25 REPARTO CUBANACÁN PLAYA LA HABANA CUBA CUBA |
| Models | 10188410024, 10188410025, 10188410027, 10188410017, 17-Hidroxiprogesterona, 10188410026, 10188410022, 10188410009, 10188410029, 10188410010, 10188410020, 10188410023 and 6 more |
| Date | Oct 3, 2018 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
- 10–99 Matching catalog numbers 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