International safety notice
Alert 2705 (Technovigilance) - Diamed Latino América S.A. - IH-500, IH-1000, Agglutination Reactions Reader - Possibility of failure of the IH-Com Quality Control module for the ABO direct test test.
Brazil / Anvisa · BRA · Oct 23, 2018
Key facts
| Title | Alert 2705 (Technovigilance) - Diamed Latino América S.A. - IH-500, IH-1000, Agglutination Reactions Reader - Possibility of failure of the IH-Com Quality Control module for the ABO direct test test. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Commercial Name: IH-500; Technical Name: Instrument intended for immunoassays ANVISA registration number: 80004040168; Risk Class: II Affected model: N/A Affected series numbers: SN 3033; |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO DIAMED LATINO AMÉRICA SA CNPJ 71015853000145 RUA ALFREDO ALBANO DA COSTA 100 DISTRITO INDUSTRIAL LAGOA SANTA MG TEL 31 36896637 EMAIL BRZRABIORADCOM FABRICANTE DO PRODUTO DIAMED LATINO AMÉRICA SA RUA ALFREDO ALBANO DA COSTA 100 DISTRITO INDUSTRIAL LAGOA SANTA MG BRASIL |
| Models | 1200534, 0500813, 0500723, 1200536, 0500687, 0500543, 1200593, 1200509, 0500749, 0300799, 80004040168, 80004040145 and 10 more |
| Date | Oct 23, 2018 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
- 10–99 Matching device models in FDA data
- 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