International safety notice
Alerta 2971 (Tecnovigilância) - Abbott – Architect: Complement C3, Immunoglobulin A, Immunoglobulin G, Immunoglobulin M, Apolipoprotein A1, Complement C4, Haptoglobin, Apolipoprotein B, Transferrin – Problemas com amostras EDTA.
Brazil / Anvisa · BRA · Aug 23, 2019
Key facts
| Title | Alerta 2971 (Tecnovigilância) - Abbott – Architect: Complement C3, Immunoglobulin A, Immunoglobulin G, Immunoglobulin M, Apolipoprotein A1, Complement C4, Haptoglobin, Apolipoprotein B, Transferrin – Problemas com amostras EDTA. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Nome Comercial: Abbott Clinical Chemistry Complement C3 - Complemento C3-Abbott Bioquimic (registro 80146501260); Immunoglobulin A / Imunoglobulina A (registro 80146501277); Abbott Clinical Chemistry Immunoglobulin G - Imunoglobulina G (IgG) Abbott Quimica (registro 80146501278); Abbott Clinical Chemistry Immunoglobulin M - Imunoglobulina M (IgM) Abbott Bioquimica (registro 80146501279); Abbott Clinical Chemistry Apolipoprotein A1 - Apolipoproteina A1 Abbott Bioquimica (registro 80146501304); Abbott Clinical Chemistry Complement C4 - Complemento C4 Abbott Bioquimica (registro 80146501270); Haptoglobin / Haptoglobina (registro 80146501681); Abbott Clinical Chemistry Apolipoprotein B - Apolipoproteína B - Abbott Bioquimica (registro 80146501262); Transferrin / Transferrina (registro 80146501682). Technical Name: Component Complement C3/C3C (registration 80146501260); ANVISA registration number: 80146501260; Risk Class: II. Modelo afetado: Architect Complement C3 (80146501260), Architect Immunoglobulin A (80146501277), Architect Immunoglobulin G (80146501278), Architect Immunoglobulin M (80146501279), Architect Apolipoprotein A1 (80146501304), Architect Complement C4 (80146501270), Architect Haptoglobin (80146501681), Architect Apolipoprotein B (80146501262), Architect Transferrin (80146501682). Number of lots of items: 38549UN18; |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO ABBOTT LABORATÓRIOS DO BRASIL LTDA CNPJ 56998701000116 RUA MICHIGAN 735 CIDADE MONÇÕES SÃO PAULO SP TEL 55 11 5536 7126 EMAIL TAMMYRODRIGUESABBOTTCOM FABRICANTE DO PRODUTO ABBOTT LABORATORIES DIAGNOSTICS DIVISION ESTADOS UNIDOS DA AMÉRICA 100 ABBOTT PARK ROAD ABBOTT PARK ILLINOIS 60064 USA ESTADOS UNIDOS DA AMÉRICA |
| Models | 86257UN18, 95217UN18, C3-Abbott, 72251UN19, 33880UN18, 55971UN18, 92054UN18, 38580UN18, 12227UN18, 12228UN18, 80146501262, 73347UN18 and 23 more |
| Date | Aug 23, 2019 |
| 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