International safety notice
Alert 2799 (Technovigilance) - Abbott Laboratórios Do Brasil Ltda - Alinity hq System Instrument Family - Possibility of incorrect CBC results if clot aspiration occurs.
Brazil / Anvisa · BRA · Feb 18, 2019
Key facts
| Title | Alert 2799 (Technovigilance) - Abbott Laboratórios Do Brasil Ltda - Alinity hq System Instrument Family - Possibility of incorrect CBC results if clot aspiration occurs. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Commercial Name: Alinity hq System Instrument Family Technical Name: Instrument for analyzing or counting cells and platelets ANVISA registration number: 80146502148 Risk Class: II Affected model: Alinity hq Analyzer Affected serial numbers: HQ00231, HQ00232, HQ00235, HQ00236, HQ00237, HQ00238, HQ00239, HQ00240 |
| 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 |
| Models | HQ00235, HQ00237, 80146502148, HQ00239, HQ00240, HQ00231, HQ00238, HQ00236, HQ00232 |
| Date | Feb 18, 2019 |
| 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