International safety notice
Alert 2759 (Technosurveillance) - Abbott - Alinity i-series Instrument Family - Possibility of unexpected amount of dry buffer residue and formation of foam/bubbles in the concentrated wash buffer reservoir.
Brazil / Anvisa · BRA · Jan 9, 2019
Key facts
| Title | Alert 2759 (Technosurveillance) - Abbott - Alinity i-series Instrument Family - Possibility of unexpected amount of dry buffer residue and formation of foam/bubbles in the concentrated wash buffer reservoir. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade Name: Alinity i-series Instrument Family Technical Name: Instrument intended for immunoassays ANVISA registration number: 80146502006 Risk Class: II Affected model: Alinity i Processing Module Affected serial numbers: Ai01085; |
| 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 GMBH CO KG MAXPLANCKRING 2 65205 WIESBADEN GERMANY ALEMANHA |
| Models | AI01193, AI01191, AI01324, AI01427, AI01421, Ai01423, AI01189, 80146502006, AI01245, AI01428, AI01202, AI01205 and 13 more |
| Date | Jan 9, 2019 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
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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