International safety notice
Alert 2608 (Technovigilance) - Biosys Ltda - GPT (ALAT) FS IFCC (MOD) Interference of Sulfasalazine and Sulfapyridine in tests based on the NAD(H) and/or NADP(H) reaction principle.
Brazil / Anvisa · BRA · Jul 11, 2018
Key facts
| Title | Alert 2608 (Technovigilance) - Biosys Ltda - GPT (ALAT) FS IFCC (MOD) Interference of Sulfasalazine and Sulfapyridine in tests based on the NAD(H) and/or NADP(H) reaction principle. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Nome Comercial: GPT (ALAT) FS IFCC (MOD) Technical Name: Pyruvic Glutamic Transaminase (TGP or ALT) ANVISA registration number: 10350840008 Risk Class: II Affected model: all 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 | 10350840008 |
| 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