International safety notice
Alert 2718 (Technosurveillance) - Siemens - Atellica IM Analyzers Family;
Brazil / Anvisa · BRA · Nov 1, 2018
Key facts
| Title | Alert 2718 (Technosurveillance) - Siemens - Atellica IM Analyzers Family; |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Commercial Name: Atellica IM Analyzers Family; Technical Name: Instrument intended for immunoassays; ANVISA registration number: 10345162195; Risk Class: II Affected model: Atellica® IM 1300 Analyzer; Números de série afetados: ATELLICA CH 930 ANALYZER: CM00236; CM00279; CM00280; CM00284; CM00285; CM00303; CM00306; CM00312; CM00314; CM00328; CM00329; CM00413; CM00462 / ATELLICA IM 1600 ANALYZER: H00234; IH00260; IH00292; IH00293; IH00302;I H00306; IH00323; IH00324; IH00327; IH00330; IH00331; IH00332; IH00340; IH00341; IH00342; IH00343; IH00344; IH00372; IH00373; IH00478; IH00479; IH00480; IH00482; IH00497; IH00501; IH00503; IH00504; IH00505 / ATELLICA SAMPLE HANDLER PRIME: SP00223; SP00240; SP00243; SP00250; SP00251; SP00268; SP00269; SP00278; SP00318; SP00319; SP00400; SP00410; SP00414. |
| 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 2132 EMAIL FELIPEDEMELOFARIASIEMENSHEALTHINEERSCOM FABRICANTE DO PRODUTO SIEMENS HEALTHCARE DIAGNOSTICS INC 511 BENEDICT AVENUE TARRYTOWN NEW YORK 10591 ESTADOS UNIDOS |
| Models | IH00340, IH00344, CM00280, IH00504, SP00243, 10345162153, IH00323, SP00250, SP00319, SP00400, IH00482, IH00501 and 44 more |
| Date | Nov 1, 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