International safety notice
Alerta 2972 (Tecnovigilância) - Abbott – Alinity: 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 2972 (Tecnovigilância) - Abbott – Alinity: 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: Alinity c Complement C3 Reagent Kit (registro 80146502194); Alinity c Immunoglobulin A Reagent Kit (registro 80146502200); Alinity c Immunoglobulin G Reagent Kit (registro 80146502202); Alinity c Immunoglobulin M Reagent Kit (registro 80146502201); Alinity c Apolipoprotein A1 Reagent Kit (registro 80146502190); Alinity c Complement C4 Reagent Kit (registro 80146502193); Alinity c Haptoglobin Reagent Kit (registro 80146502146); Alinity c Apolipoprotein B Reagent Kit (registro 80146502192); Familia Alinity c Transferrin (registro 80146502135). Technical Name: Component Complement C3/C3C (registration 80146502194); ANVISA registration number: 80146502194; Risk Class: II. Modelo afetado: Alinity Complement C3 (80146502194), Alinity Immunoglobulin A (80146502200), Alinity Immunoglobulin G (80146502202), Alinity Immunoglobulin M (80146502201), Alinity Apolipoprotein A1 (80146502190), Alinity Complement C4 (80146502193), Alinity Haptoglobin (80146502146), Alinity Apolipoprotein B (80146502192), Alinity Transferrin (80146502135). Affected batch numbers: 86485UN18, 83115UN19, 11562UN18 and 82997UN18. |
| 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 GMBH CO KG ALEMANHA MAXPLANCKRING 2 65205 WIESBADEN GERMANY ALEMANHA |
| Models | 80146502201, 83115UN19, 80146502190, 80146502200, 80146502193, 80146502194, 82997UN18, 86485UN18, 11562UN18, 80146502192, 80146502146, 80146502202 and 1 more |
| Date | Aug 23, 2019 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
- 10–99 Matching device models in FDA data
- 10–99 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