International safety notice
Technical name: SODIUM
Brazil / Anvisa · BRA · Mar 20, 2017
Key facts
| Title | Technical name: SODIUM |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Commercial name: REACTIVE DRY VITROS* FOR SODIUM Na Technical name: SODIUM ANVISA registration number: 10132590216 Risk class: II Affected model: Box with 25 envelopes with 1 slide each / Box with 5 cartridges with 50 slides each Affected serial numbers: All VITROS Sodium Slides with SKU 8379034, generations 1 through 6, 30 through 40 and 44 through 49. Since this action affects all expired, expired and future generations, all customers with equipment compatible with the slides will be notified VITROS 250, VITROS 350, VITROS 5.1 FS, VITROS 4600 CHEMISTRY, VITROS 3600 IMMUNODIAGNOSTIC and VITROS 5600 INTEGRATED. |
| 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 DA AMÉRICA |
| Models | 10132590216, 8379034 |
| Date | Mar 20, 2017 |
| 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