International safety notice
Alert 2548 (Technovigilance) Biosys - oneHbA1c IS Risk of incorrect results, due to instability of reagents at temperature.
Brazil / Anvisa · BRA · Apr 19, 2018
Key facts
| Title | Alert 2548 (Technovigilance) Biosys - oneHbA1c IS Risk of incorrect results, due to instability of reagents at temperature. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade name: OneHbA1c IS Technical name: Glycosylated hemoglobin ANVISA registration number: 10350840200 Risk class: II Affected model: 100 cartridges (R1:350uL/R2:75uL/R3:80uL) + 10 Cleaner tubes (1800uL) + Paramcard Affected Lot/Series Numbers: 60121004; |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO BIOSYS LTDA CNPJ 02220795000179 RUA CORONEL GOMES MACHADO 358 NITERÓI RJ TEL 2139072534 EMAIL REGULATORIOSBIOSYSCOMBR FABRICANTE DIASYS DIAGNOSTIC SYSTEMS GMBH ALTE STRASSE 9 65558 HOLZHEIM ALEMANHA |
| Models | OneHbA1c, 60121001, 60119656, 350uL, 60121004, 1800uL, 10350840200, 60119264 |
| Date | Apr 19, 2018 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
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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