International safety notice
Alert 2610 (Technovigilance) - Kovalent Do Brasil Ltda - CKMB and CKMB DS - Interference of Sulfasalazine in tests based on the NAD(H) and/or NADP(H) reaction principle.
Brazil / Anvisa · BRA · Jul 11, 2018
Key facts
| Title | Alert 2610 (Technovigilance) - Kovalent Do Brasil Ltda - CKMB and CKMB DS - Interference of Sulfasalazine in tests based on the NAD(H) and/or NADP(H) reaction principle. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade Name: CKMB and CKMB DS Technical Name: Creatine phosphokinase isoenzyme activity ANVISA registration numbers: 80115310126; Risk Class: III Affected model: all Affected serial numbers: all product batches |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO KOVALENT DO BRASIL LTDA CNPJ 04842199000156 RUA CRISTOVÃO SARDINHA 110 JARDIM BOM RETIRO SÃO GONÇALO RJ TEL 2139072534 EMAIL REGULATORIOSBIOSYSCOMBR FABRICANTE DO PRODUTO KOVALENT DO BRASIL LTDA RUA CRISTOVÃO SARDINHA 110 JARDIM BOM RETIRO BRASIL |
| Models | 80115310126, 80115310043 |
| Date | Jul 11, 2018 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
- 1–9 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