International safety notice
Alert 2543 (Technosurveillance) - Mex Global - PTS PANELS CHOL+GLU Test Panel Test Strips Potential for incorrect (lower) results.
Brazil / Anvisa · BRA · Apr 17, 2018
Key facts
| Title | Alert 2543 (Technosurveillance) - Mex Global - PTS PANELS CHOL+GLU Test Panel Test Strips Potential for incorrect (lower) results. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Nome comercial: PTS PANELS CHOL+GLU Test Panel Test Strips Technical name: Total Cholesterol ANVISA registration number: 80812770002 Risk class: II Affected model: 1 box with 1 bottle with 25 test strips and desiccant, 1 MEMo CHIP microprocessor> Affected serial numbers: A707 |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO MEX GLOBAL EQUIPAMENTOS PARA DIAGNÓSTICOS LTDA CNPJ 11098622000110 RUA SAMUEL MORSE 120 3O ANDAR CONJUNTO 31 SÃO PAULO SP TEL 11 26632548 EMAIL LEILACUXENIERMEXGLOBALCOM FABRICANTE POLYMER TECHNOLOGY SYSTEMS INC 7736 ZIONSVILLE ROAD INDIANAPOLIS IN 46268 ESTADOS UNIDOS TELEFONE 1 3178705610 EMAIL HSTRUNKPTSDIAGNOSTICSCOM |
| Models | 80812770002 |
| Date | Apr 17, 2018 |
| 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