International safety notice
Alert 2791 (Technovigilance) - Biomérieux - Vitek 2 ID / AST Cards - Possibility that defects in the sealing of specific batches cause the entry of moisture, which causes changes in test results.
Brazil / Anvisa · BRA · Jan 29, 2019
Key facts
| Title | Alert 2791 (Technovigilance) - Biomérieux - Vitek 2 ID / AST Cards - Possibility that defects in the sealing of specific batches cause the entry of moisture, which causes changes in test results. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade Name: Vitek 2 ID/AST Cards Technical Name: Device for Identification and Antibiogram of microorganisms ANVISA registration number: 10158120592 Risk Class: Class II Affected Model: Vitek 2 ID/AST Cards Affected serial numbers: Ref. 21342 Lot: 2420806103; |
| 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 TEL 21 24441415 EMAIL SUELENSILVABIOMERIEUXCOM FABRICANTE DO PRODUTO BIOMÉRIEUX INC 595 ANGLUM ROAD HAZEWOOD MO 63042 ESTADOS UNIDOS DAS AMÉRICAS |
| Models | 21342, 2420806103, 21341, 2410635203, 2880809203, 2880812203, 10158120592, 420739, 21347, 2440811203 |
| Date | Jan 29, 2019 |
| 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