International safety notice
Alert 2569 (Technovigilance) - KOVALENT DO BRASIL LTDA - HbA1c KIT Possibility of deviations in results due to the possible instability of some batches of the reagent.
Brazil / Anvisa · BRA · May 9, 2018
Key facts
| Title | Alert 2569 (Technovigilance) - KOVALENT DO BRASIL LTDA - HbA1c KIT Possibility of deviations in results due to the possible instability of some batches of the reagent. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Commercial Name: HbA1c KIT. Technical Name: Glycosylated hemoglobin. ANVISA registration number: 80115310145. Risk Class: II. Affected model: R1:2x15mL + R2:1x10mL + R3:1x5mL. Affected serial numbers: 1084091744, 1084091745, 1084091846. |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO KOVALENT DO BRASIL LTDA RUA CRISTOVÃO SARDINHA 110 JARDIM BOM RETIRO SÃO GONÇALO RJ TEL 2139072534 EMAIL REGULATORIOSBIOSYSCOMBR FABRICANTE DO PRODUTO KOVALENT DO BRASIL RUA CRISTOVÃO SARDINHA 110 BRASIL |
| Models | 1084091744, HbA1c, 80115310145, 1084091745, 1084091846 |
| Date | May 9, 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