International safety notice
Alert 2730 (Technosurveillance) - Abbott - ARCHITECT HAVAb-IgG Rgt Kit;
Brazil / Anvisa · BRA · Nov 9, 2018
Key facts
| Title | Alert 2730 (Technosurveillance) - Abbott - ARCHITECT HAVAb-IgG Rgt Kit; |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Nome Comercial: ARCHITECT HAVAb-IgG Rgt Kit; ARCHITECT HAVAb-IgM Rgt Kit; Alinity i HAVAb IgG Reagent Kit Technical Name: Hepatitis A Virus (HAV) ANVISA registration number: 80146501196; Risk Class: III Affected model: 100/400 tests and 200/1000 tests Números de série afetados: ARCHITECT HAVAb-IgG Reagent Kit: 90356LI00 / 90360LI00 / 87316LI00 / 87317LI00. ARCHITECT HAVAb-IgM Reagent Kit: 90228LI00 / 91012LI00 / 87006LI00 / 87306LI00 / 89081LI00 / 87007LI00 / 89082LI00 / 89248LI00. Alinity i HAVAb IgG Reagent Kit: 87322LI00 e 88245LI00. |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO ABBOTT LABORATÓRIOS DO BRASIL LTDA RUA MICHIGAN 735 CIDADE MONÇÕES SÃO PAULO SP TEL 55 11 5536 7126 EMAIL TAMMYRODRIGUESABBOTTCOM FABRICANTE DO PRODUTO ABBOTT GMBH CO KG MAXPLANCKRING 2 65205 WIESBADEN GERMANY ALEMANHA |
| Models | 90228LI00, 87006LI00, 87316LI00, 90360LI00, 91012LI00, 90356LI00, 80146501196, 87322LI00, 87317LI00, 88245LI00, 87007LI00, 89082LI00 and 5 more |
| Date | Nov 9, 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