International safety notice
Alert (Technosurveillance) - Biomérieux - Vidas LH Calibrator S1 with low value for the VIDAS LH kit, resulting in a message Invalid Calibration
Brazil / Anvisa · BRA · Mar 13, 2018
Key facts
| Title | Alert (Technosurveillance) - Biomérieux - Vidas LH Calibrator S1 with low value for the VIDAS LH kit, resulting in a message Invalid Calibration |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade name: Vidas LH Technical name: Luteinizing Hormone LH ANVISA registration number: 10158120127 Risk class: II Affected model: Not applicable Affected serial number: Lot: 1005940920 |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO BIOMÉRIEUX BRASIL INDÚSTRIA E COMÉRCIO DE PRODUTOS LABORATORIAIS LTDA CNPJ 33040635000171 ESTRADA DO MAPUÁ 491 LOTE 1 TAQUARA JACAREPAGUÁ RIO DE JANEIRO RJ FABRICANTE BIOMÉRIEUX SA CHEMIN DE LORME 69280 MARCY LETOILE FRANÇA TELEFONE 33 04 78 87 20 00 FAX 33 04 78 87 20 90 EMAIL ANNEJACQUETINMARCHANDBIOMERIEUXCOM |
| Models | 10158120127, 1005940920 |
| Date | Mar 13, 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