International safety notice
Alert 2814 (Technosurveillance) - Abbott - Alinity hq System Instrument Family, Alinity hs Instrument Family - Possibility of failure in the safety lock covering the septum piercing probes.
Brazil / Anvisa · BRA · Mar 12, 2019
Key facts
| Title | Alert 2814 (Technosurveillance) - Abbott - Alinity hq System Instrument Family, Alinity hs Instrument Family - Possibility of failure in the safety lock covering the septum piercing probes. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Commercial Name: Alinity hq System Instrument Family (80146502148); Technical Name: Instrument for analyzing or counting cells and platelets (80146502148); ANVISA registration number: 80146502148; Risk Class: II (80146502148); Modelo afetado: Alinity hq Analyzer (80146502148); Alinity hs Slide Maker Stainer Module - Alinity hs Slide Maker Stainer Module (80146502143). Affected serial numbers: HQ00231, HQ00232, HQ00235, HQ00236, HQ00237, HQ00238, HQ00239, HQ00240, HQ00275, HQ00280, HQ00301, HQ00304, HQ00305, HQ00308, HQ00 310, HQ00311, HS00129, HS00133, HS00135, HS00137, HS00158, HS00160, HS00161 , HS00162. |
| 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 ALEMANHA MAXPLANCKRING 2 65205 WIESBADEN ALEMANHA ALEMANHA |
| Models | HQ00237, HS00129, HS00135, 80146502148, HQ00301, HQ00235, 80146502143, HS00161, HQ00238, HQ00310, HQ00236, HQ00308 and 14 more |
| Date | Mar 12, 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