International safety notice
IMMUNOHEMATOLOGY - ABO - MONOCLONAL ORIGIN
Brazil / Anvisa · BRA · Feb 10, 2016
Key facts
| Title | IMMUNOHEMATOLOGY - ABO - MONOCLONAL ORIGIN |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | DUOLYS, IMMUNOHEMATOLOGY - ABO - MONOCLONAL ORIGIN, registration 10154450118, model: 12 DuoLys microplates for 12 x 8 ABO-RH1 typing and RH-K phenotyping (each microplate contains 8 wells of Anti-A, Anti-B, Anti-A,B , Anti-D, Anti-C, Anti-c, Anti-E, Anti-e, Anti-K, Negative Control and 2 x 8 empty wells) + 1 vial of 40 mL of MagneLys, risk class IV, lots: 206000, 229000, 234000, 230000. /// PHENOLYS, IMMUNOHEMATOLOGY - RH-HR - MONOCLONAL ORIGIN, registration 10154450120, model: 12 PhenoLys microplates for 12 x 16 RH-K phenotyping (each microplate contains 2 x 8 negative control wells, Anti-C, Anti-E, Anti-c, Anti-e, Anti-K) + 1 vial of 40 mL of MagneLys, risk class IV, lots: 618000, 619000, 620000. |
| Manufacturer | DETENTOR DO REGISTRO FRESENIUS HOMECARE BRASIL LTDA ENDEREÇO RUA ROQUE GONZALES 128 ITAPECERICA DA SERRA SP FABRICANTE DIAGAST ENDEREÇO 251 AVENUE EUGÈNE AVINÉE FRANÇA |
| Models | 10154450120, 234000, 619000, 620000, 10154450118, 206000, 230000, 229000, 618000, ABO-RH1 |
| Date | Feb 10, 2016 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
- 10–99 Matching device models in FDA data
- 10–99 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