International safety notice
Technical name: Reag for immunohematology - Reag of red blood cells/red blood cells treated with enzymes
Brazil / Anvisa · BRA · Dec 2, 2016
Key facts
| Title | Technical name: Reag for immunohematology - Reag of red blood cells/red blood cells treated with enzymes |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Commercial name: Family of red blood cell reagents for immunohematology R4 - IH Biovue - Other items in annex 1st Technical name: Reag for immunohematology - Red blood cell reagent/red blood cells treated with enzymes ANVISA registration number: 80145901444 Risk class: IV Affected model : Surgiscreen -Set of three vials with 3mL each of cell for detection of unexpected antibodies Affected serial numbers: 3SS214Z; |
| 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 LOCALIZADA EM 1001 US HIGHWAY 202 RARITAN NEW JERSEY ESTADOS UNIDOS |
| Models | 8SS282, 8SS280, 3SS225Z, 8SS274, 8EA329, 8ª534, 3SS238Z, 8RC308, 8SS275, 8RA330, 8S896, 3SS231Z and 26 more |
| Date | Dec 2, 2016 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
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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