International safety notice
Technical Name: Glycated hemoglobin
Brazil / Anvisa · BRA · May 19, 2016
Key facts
| Title | Technical Name: Glycated hemoglobin |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Commercial name: 31 Vitros Calibrator Kit ANVISA registration number: 80145901715 Technical Name: Glycated hemoglobin Risk class: Product classified as II and control of these systems is carried out by batch number Affected model: 119 units of the calibration kit were imported which together with the Assay Data Diskette (ADD) versions 5873, 5874, 5875 and 5876 will not be possible to be calibrated |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO JOHNSON JOHNSON DO BRASIL IND E COM DE PROD PARA SAÚDE LTDA CNPJ 54516661000101 RUA GERIVATIVA Nº 207 SÃO PAULO SP FABRICANTE ORTHO CLINICAL DIAGNOSTICS INC LOCALIZADA NOS EUA |
| Models | 80145901715 |
| Date | May 19, 2016 |
| 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