International safety notice
Alert 2603 (Technovigilance) - Siemens Healthcare Diagnósticos Ltda - Flex Reagent for Dimension Gentamicin Possibility of inaccuracy in the lower limit of the analytical measurement range.
Brazil / Anvisa · BRA · Jul 9, 2018
Key facts
| Title | Alert 2603 (Technovigilance) - Siemens Healthcare Diagnósticos Ltda - Flex Reagent for Dimension Gentamicin Possibility of inaccuracy in the lower limit of the analytical measurement range. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade Name: Flex Reagent for Dimension Gentamicin Technical Name: Gentamicin ANVISA registration number: 10345161291 Risk Class: II Affected model: N/A Affected serial numbers: EB8115; |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO SIEMENS HEALTHCARE DIAGNÓSTICOS LTDA CNPJ 01449930000190 AV MUTINGA 3800 4º E 5º ANDAR PIRITUBA SÃO PAULO SP TEL 11 3908 2953 EMAIL BEATRIZDIASSIEMENSHEALTHINEERSCOM FABRICANTE DO PRODUTO SIEMENS HEALTHCARE DIAGNOSTICS INC 500 GBC DRIVE MAILSTOP 514 PO BOX 6101 NEWARK DELAWARE 197146101 ESTADOS UNIDOS |
| Models | BB8159, 10345161291, EB8115, FB8275 |
| Date | Jul 9, 2018 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
- 10–99 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