International safety notice
Alert 2702 (Technovigilance) - Abbott Laboratórios Do Brasil Ltda - Alinity i-series Instrument Family - Possibility of leakage of bulk solution resulting in pump failure.
Brazil / Anvisa · BRA · Oct 19, 2018
Key facts
| Title | Alert 2702 (Technovigilance) - Abbott Laboratórios Do Brasil Ltda - Alinity i-series Instrument Family - Possibility of leakage of bulk solution resulting in pump failure. |
|---|---|
| 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 Modelo afetado: Alinity i Processing Module - Alinity i Processing Module Affected serial numbers: Ai01085, AI01187, AI01189, AI01191, AI01192, AI01199, AI01200, AI01202, AI01205, AI01207, AI01240, AI01241, AI01245, AI01193 |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO ABBOTT LABORATÓRIOS DO BRASIL LTDA RUA MICHIGAN 735 CIDADE MONÇÕES SÃO PAULO SP TEL 55 11 5536 7356 EMAIL CAMILAFERREIRAABBOTTCOM FABRICANTE DO PRODUTO ABBOTT GMBH CO KG MAXPLANCKRING 2 65205 WIESBADEN GERMANY ALEMANHA |
| Models | AI01189, AI01187, AI01191, AI01207, 80146502006, AI01205, AI01200, AI01192, AI01241, AI01240, Ai01085, AI01193 and 3 more |
| Date | Oct 19, 2018 |
| 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