International safety notice
Alert 2821 (Technovigilance) - Abbott Laboratórios do Brasil Ltda - Architect Estradiol Reagents - Alinity i Estradiol Reagent Kit - Possibility of interference of the drug mifepristone in the results.
Brazil / Anvisa · BRA · Mar 19, 2019
Key facts
| Title | Alert 2821 (Technovigilance) - Abbott Laboratórios do Brasil Ltda - Architect Estradiol Reagents - Alinity i Estradiol Reagent Kit - Possibility of interference of the drug mifepristone in the results. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Nome Comercial: Architect Estradiol Reagents (registro 80146501210); Alinity i Estradiol Reagent Kit (registro 80146502096) Technical Name: Estradiol ANVISA registration number: 80146501210; Risk Class: II Affected model: All reagents Números de série afetados: Architect Estradiol Reagents (registro 80146501210): 87183UI00, 89225UI00, 91454UI00, 93011UI00, 94074UI00, 93537UI00, 89230UI00, 87188UI00, 91449UI00, 93520UI00, 94069UI00 e 94301UI00. Alinity i Estradiol Reagent Kit (registro 80146502096): 89177UI00. |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO ABBOTT LABORATÓRIOS DO BRASIL LTDA CNPJ 56998701000116 RUA MICHIGAN 735 CIDADE MONÇÕES SÃO PAULO SP TEL 55 11 5536 73126 EMAIL CAMILAFERREIRAABBOTTCOM FABRICANTE DO PRODUTO ABBOTT IRELAND DIAGNOSTICS DIVISION IRLANDA LISNAMUCK LONGFORD CO LONGFORD IRELAND IRLANDA |
| Models | 94301UI00, 93537UI00, 93011UI00, 89230UI00, 91454UI00, 94069UI00, 93520UI00, 94074UI00, 80146501210, 87183UI00, 89225UI00, 89177UI00 and 3 more |
| Date | Mar 19, 2019 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
- 1–9 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