International safety notice
Alert 2651 (Technosurveillance) - Siemens Healthcare Diagnósticos Ltda - Rapidpoint 500 System / Rapidlab 1200 Systems - Hydroxocobalamin Interference.
Brazil / Anvisa · BRA · Aug 23, 2018
Key facts
| Title | Alert 2651 (Technosurveillance) - Siemens Healthcare Diagnósticos Ltda - Rapidpoint 500 System / Rapidlab 1200 Systems - Hydroxocobalamin Interference. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Nome Comercial: Rapidpoint 500 System / Rapidlab 1200 Systems Technical Name: Instrument for analyzing blood gases, ions or pH / Instrument for analyzing general biochemistry, hormones, drugs or proteins ANVISA registration number: 10345161877; Risk Class: II Affected model: Rapidpoint 500 / RapidLab 1265 Blood Gas Analyzer Affected serial numbers: See attachment "List of serial numbers at risk" in the alert published on the Anvisa website |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO SIEMENS HEALTHCARE DIAGNÓSTICOS LTDA AV MUTINGA 3800 4º E 5º ANDAR PIRITUBA SÃO PAULO SP TEL 11 3908 2132 EMAIL FELIPEDEMELOFARIASIEMENSHEALTHINEERSCOM FABRICANTE DO PRODUTO SIEMENS HEALTHCARE DIAGNOSTICS INC 511 BENEDICT AVENUE TARRYTOWN NEW YORK 10591 ESTADOS UNIDOS |
| Models | 10345161877, 10345160455 |
| Date | Aug 23, 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