International safety notice
Alert 2501 (Technosurveillance) - bioMerieux - Etest Family The ETEST product Polymyxin B can no longer be recommended for use with strains of Pseudomonas aeruginosa or Acinetobacter, as it may lead to false susceptible results.
Brazil / Anvisa · BRA · Feb 27, 2018
Key facts
| Title | Alert 2501 (Technosurveillance) - bioMerieux - Etest Family The ETEST product Polymyxin B can no longer be recommended for use with strains of Pseudomonas aeruginosa or Acinetobacter, as it may lead to false susceptible results. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade name: Etest Family Technical name: Device for Microorganism Identification/Antibiogram ANVISA registration number: 10158120623 Risk class: II Affected model: Etest Polymyxin B Affected serial number: 1002446640; |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO BIOMERIEUX BRASIL IND E COM DE PROD LABORATORIAIS LTDA CNPJ 33040635000171 ESTRADA DO MAPUÁ 491 LOTE 1 TAQUARA RIO DE JANEIRO RJ FABRICANTE BIOMERIEUX SA 3 ROUTE DE PORT MICHAUD 38390 LA BALME LES GROTTES FRANÇA TELEFONE 33478877422 FAX 33489430005 EMAIL SOPHIEDUCONGEREXTBIOMERIEUXCOM |
| Models | 1005945380, 1005161530, 1004955950, 1003322180, 1002797130, 1005753830, 1002762220, 1004767110, 1004370570, 1003719640, 10044414690, 1003187220 and 39 more |
| Date | Feb 27, 2018 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
- 1–9 Matching device models 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