International safety notice
Alert 2800 (Technovigilance) - Abbott Laboratórios do Brasil Ltda - Cell-Dyn Emerald - Possibility that the analyzer generates low or out-of-range quality control for the RBC and PLT parameters.
Brazil / Anvisa · BRA · Mar 7, 2019
Key facts
| Title | Alert 2800 (Technovigilance) - Abbott Laboratórios do Brasil Ltda - Cell-Dyn Emerald - Possibility that the analyzer generates low or out-of-range quality control for the RBC and PLT parameters. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Nome Comercial: Cell-Dyn Emerald Technical Name: Instrument for analyzing or counting cells and platelets ANVISA registration number: 80146501612 Risk Class: II Affected model: Cell-Dyn Emerald Hematology Analyzer Affected serial numbers: 34010001484, 34010001496, 34010001494, 34010001404, 34010001419, 34010001492, 34010001407, 34810001757, 34109000953 , 31511002345, 34010001425, 34010001449, 34010001446, 34010001482, 32413005026, 30611002111, 30514005356. |
| 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 LABORATORIES DIAGNOSTICS DIVISION ESTADOS UNIDOS DA AMÉRICA 100 ABBOTT PARK ROAD ABBOTT PARK ILLINOIS 60064 USA ESTADOS UNIDOS DA AMÉRICA |
| Models | 34010001449, 34010001425, 30611002111, 34010001494, 34010001419, 34010001404, 34109000953, 34010001446, 32413005026, 34010001482, 34010001492, 34010001496 and 6 more |
| Date | Mar 7, 2019 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
- 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