International safety notice
Alert 2843 (Technosurveillance) Abbott Laboratórios do Brasil Ltda Abbott RealTime HBV Control Kit;
Brazil / Anvisa · BRA · Apr 12, 2019
Key facts
| Title | Alert 2843 (Technosurveillance) Abbott Laboratórios do Brasil Ltda Abbott RealTime HBV Control Kit; |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Nome Comercial: Abbott RealTime HBV Control Kit (80146501584); Abbott RealTime CMV Control Kit (80146502016) Technical Name: Viral Load Monitoring Hepatitis B Virus (HBV) (80146501584); ANVISA registration number: 80146501584; Risk Class: III Affected model: Registration 80146501584: Pack with 24 vials: Negative Control - 8x1.3mL; Affected serial numbers: 484469, 487556, 488125, and 485936. |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO ABBOTT LABORATÓRIOS DO BRASIL LTDA CNPJ 56998701000116 RUA MICHIGAN 735 CIDADE MONÇÕES SÃO PAULO SP TEL 55 11 5536 7477 EMAIL ANAPAULASILVAABBOTTCOM FABRICANTE DO PRODUTO ABBOTT MOLECULAR INC DES PLAINES IL 60018 USA ESTADOS UNIDOS |
| Models | 488125, 80146502016, 80146501584, 485936, 487556, 484469 |
| Date | Apr 12, 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