International safety notice
Technical name: PHENYTOIN
Brazil / Anvisa · BRA · Dec 18, 2016
Key facts
| Title | Technical name: PHENYTOIN |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade name: REACTIVE SECO VITROS* FOR PHENYTOIN PHYT Technical name: PHENYTOIN ANVISA registration number: 10132590219 Risk class: II Affected model: REACTIVE SECO VITROS* FOR PHENYTOIN PHYT 5 cartridges with 18 slides Affected serial numbers: VITROS Chemistry Products PHYT Slides , product code 8298671, batches: 1401566241, 1401566904, 1401577638, 1401577639, 1401578552, 1401578568, 1401580410, 1401589627, 14015912 30, 1401592935, 1401604105, and 1401614738. Assay Data Diskette (ADD) and Calibration 16607 products are not applicable. |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO JOHNSON JOHNSON DO BRASIL IND E COM DE PROD PARA SAÚDE LTDA CNPJ 54516661000101 LOCALIZADA NA AV JUSCELINO KUBITSCHEK Nº 2041 ANDARES 8º E 9º COMPLEXO JK BLOCO B SÃO PAULO SP FABRICANTE ORTHOCLINICAL DIAGNOSTICS INC 100 INDIGO CREEK DRIVE ROCHESTER NY 146265101 ESTADOS UNIDOS |
| Models | 8298671, 1401577639, 1401614738, 1401578552, 1401604105, 1401566904, 10132590219, 1401580410, 1401566241, 1401577638, 1401591230, 1401589627 and 3 more |
| Date | Dec 18, 2016 |
| 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