International safety notice
Alert 2607 (Technovigilance) - Biosys Ltda - CKMB FS - Sulfasalazine interference in tests based on the NAD(H) and NADP(H) reaction principle.
Brazil / Anvisa · BRA · Jul 11, 2018
Key facts
| Title | Alert 2607 (Technovigilance) - Biosys Ltda - CKMB FS - Sulfasalazine interference in tests based on the NAD(H) and NADP(H) reaction principle. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade Name: CKMB FS Technical Name: Creatine phosphokinase isoenzyme activity ANVISA registration number: 10350840005 Risk Class: III Affected model: R1 5X20mL+ R2 1X25mL; Affected serial numbers: all batches of the product mentioned in this notification |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO BIOSYS LTDA CNPJ 02220795000179 RUA CORONEL GOMES MACHADO 358 NITERÓI RJ TEL 2139072534 EMAIL REGULATORIOSBIOSYSCOMBR FABRICANTE DO PRODUTO DIASYS DIAGNOSTIC SYSTEMS GMBH ALTE STRASSE 9 65558 HOLZHEIM ALEMANHA |
| Models | 10350840005 |
| Date | Jul 11, 2018 |
| 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