International safety notice
Technical name: Immunohematology - Red Blood Cell Reagents / Red Blood Cells treated with Enzymes
Brazil / Anvisa · BRA · Aug 3, 2017
Key facts
| Title | Technical name: Immunohematology - Red Blood Cell Reagents / Red Blood Cells treated with Enzymes |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Nome comercial: Diamed - Id-Diapanel Technical name: Immunohematology - Red Blood Cell Reagents / Red Blood Cells treated with Enzymes ANVISA registration number: 80004040131 Risk class: IV Affected model: 00 000 000 0041 14 Affected serial numbers: Kit Lot: 45161.94.1 (Kit: ID-DiaPanel) Batch of red blood cell reagent ID-DiaPanel 5: 06211.94.1 (red cell reagent in which the problem was identified). ID-DiaPanel 5 Red Blood Cell Reactive Bottle Numbers Lot 06211.94.1 in which the problem was identified: 000007, 00009, 000010, 000013, 000014, and 000018. The bottles whose serial numbers are 000015, 000020 and 000030, the respective Customers did not test the antigens and replacement was carried out as a containment measure. |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO DIAMED LATINO AMÉRICA SA CNPJ 71015853000145 RUA ALFREDO ALBANO DA COSTA 100 DISTRITO INDUSTRIAL LAGOA SANTA MG FABRICANTE DIAMED LATINO AMÉRICA SA RUA ALFREDO ALBANO DA COSTA 100 DISTRITO INDUSTRIAL LAGOA SANTA MG EMAIL BRZRABIORADCOM TELEFONE 31 36896637 |
| Models | 000015, 06211.94.1, 000030, 45161.94.1, 00009, 80004040131, 000013, 000007, 000010, 000018, 000014, 000020 |
| Date | Aug 3, 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