International safety notice
Alert 2602 (Technovigilance) - Abbott Laboratórios do Brasil Ltda - i-Stat Chem8+ Cartridge Possibility of generating high sodium results.
Brazil / Anvisa · BRA · Jul 9, 2018
Key facts
| Title | Alert 2602 (Technovigilance) - Abbott Laboratórios do Brasil Ltda - i-Stat Chem8+ Cartridge Possibility of generating high sodium results. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade Name: i-Stat Chem8+ Cartridge Technical Name: Parameters Combined In The Same Product ANVISA registration number: 80146501578 Risk Class: II Affected model: N/A Affected serial numbers: H18089E; |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO ABBOTT LABORATÓRIOS DO BRASIL LTDA CNPJ 56998701000116 RUA MICHIGAN 735 CIDADE MONÇÕES SÃO PAULO SP TEL 55 11 5536 7477 EMAIL ANAPAULASILVAABBOTTCOM FABRICANTE DO PRODUTO ABBOTT POINT OF CARE INC 100 AND 200 ABBOTT PARK RD ABBOTT PARK IL 60064 USA ESTADOS UNIDOS |
| Models | 80146501578, Chem8, H18089E, H18090, H18091B, H18090A |
| Date | Jul 9, 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