International safety notice
Alert 2534 (Technosurveillance) Biomérieux Ltda - FilmArray BCID Panel - Increased risk of false positive Proteus results.
Brazil / Anvisa · BRA · Apr 6, 2018
Key facts
| Title | Alert 2534 (Technosurveillance) Biomérieux Ltda - FilmArray BCID Panel - Increased risk of false positive Proteus results. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade name: FilmArray BCID Panel Technical name: Parameters combined in the same product ANVISA registration number: 10158120695 Risk class: III Affected model: Not applicable Affected Lot/Series Numbers: 538617 / 538517 / 545518 |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO BIOMÉRIEUX BRASIL INDÚSTRIA E COMÉRCIO DE PRODUTOS LABORATORIAIS LTDA CNPJ 33040635000171 ESTRADA DO MAPUÁ 491 LOTE 1 TAQUARA JACAREPAGUÁ RJ RIO DE JANEIRO TEL 21 24441415 SUELENSILVABIOMERIEUXCOM FABRICANTE BIOFIRE DIAGNOSTICS LLC 515 COLOROW DRIVE SALT LAKE CITY UTAH 84108 EUA |
| Models | 10158120695, 545518, 538617, 538517 |
| Date | Apr 6, 2018 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
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