International safety notice
Alert 2724 (Technosurveillance) - Abbott - Alinity i Free T3 Reagent Kit, Architect Free T3 Reagent Kit, Architect Total T3 Reagent Kit - Possibility of falsely low results in samples tested with specific assays.
Brazil / Anvisa · BRA · Nov 7, 2018
Key facts
| Title | Alert 2724 (Technosurveillance) - Abbott - Alinity i Free T3 Reagent Kit, Architect Free T3 Reagent Kit, Architect Total T3 Reagent Kit - Possibility of falsely low results in samples tested with specific assays. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Commercial Name: Alinity i Free T3 Reagent Kit; Technical Name: Triiodothyronine (T3) Free ANVISA registration number: 80146502063; Risk Class: II Affected model: See attachment List of lots at risk Affected batch numbers: All. |
| 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 TAMMYRODRIGUESABBOTTCOM FABRICANTE DO PRODUTO ABBOTT IRELAND DIAGNOSTICS DIVISION LISNAMUCK LONGFORD CO LONGFORD IRELAND |
| Models | 80146502063, 80146502023, 80146502024 |
| Date | Nov 7, 2018 |
| 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