International safety notice
Alert 2504 (Technosurveillance) - Sysmex - E-Check Family - Sysmex (Xn Check) Increase in the inaccuracy of lymphocyte counts
Brazil / Anvisa · BRA · Feb 28, 2018
Key facts
| Title | Alert 2504 (Technosurveillance) - Sysmex - E-Check Family - Sysmex (Xn Check) Increase in the inaccuracy of lymphocyte counts |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade name: E-Check Family - Sysmex (Xn Check) Technical name: Parameters combined in the same product ANVISA registration number: 80015490061 Risk class: II Affected Model: 12 Bottles X3.0 Ml of Each Level (Level 1, Level 2, Level 3) Affected serial number: 7320, 8011, 8067 |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO SYSMEX DO BRASIL INDÚSTRIA E COMÉRCIO LTDA CNPJ 02923414000118 RUA JOAQUIM NABUCO 615 CIDADE JARDIM SÃO JOSÉ DOS PINHAIS PR FABRICANTE SYSMEX CORPORATION JAPAN 151 WAKINOHAMA KAIGANDORI CHUO KU KOBE 6510073 TELEFONE 4121041376 FAX 4121041314 EMAIL RAFAELAGUARISESYSMEXCOMBR |
| Models | 80015490061 |
| Date | Feb 28, 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