International safety notice
Alert 2685 (Technovigilance) - Sysmex do Brasil Indústria e Comércio Ltda - Fluorocell Possibility of results of fluorescent platelets and immature platelet fraction lower than expected in specific batches.
Brazil / Anvisa · BRA · Sep 27, 2018
Key facts
| Title | Alert 2685 (Technovigilance) - Sysmex do Brasil Indústria e Comércio Ltda - Fluorocell Possibility of results of fluorescent platelets and immature platelet fraction lower than expected in specific batches. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Nome Comercial: Fluorocell Technical Name: Cytological Dyes ANVISA registration number: 80015490092 Risk Class: I Affected model: Fluorocell PLT - 2 X 12mL Affected serial numbers or lots: A7126, A7129 |
| 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 TEL 21041376 EMAIL RAFAELAGUARISESYSMEXCOMBR FABRICANTE DO PRODUTO SYSMEX CORPORATION JAPAN 151 WAKINOHAMA KAIGANDORI CHUO KU KOBE 6510073 JAPAN |
| Models | 80015490092, A7126, A7129 |
| Date | Sep 27, 2018 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
- 1–9 Matching device models in FDA data
- 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