International safety notice
Alert 2709 (Technovigilance) - Fresenius Hemocare Brasil Ltda - FR3mL Red Blood Cell Panel Reagent - Incorrect information in the specific batch diagram, with consequent divergence in information on the intensity of the reaction.
Brazil / Anvisa · BRA · Oct 25, 2018
Key facts
| Title | Alert 2709 (Technovigilance) - Fresenius Hemocare Brasil Ltda - FR3mL Red Blood Cell Panel Reagent - Incorrect information in the specific batch diagram, with consequent divergence in information on the intensity of the reaction. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade Name: FR3ML Red Blood Cell Panel Reagent Technical Name: Immunohematology - Red Blood Cells/Red Blood Cells Reagents Treated with Enzymes ANVISA registration number: 10154450145 Risk Class: IV Affected model: BSA Red Cell Panel - 12 vials x 3 mL Affected serial numbers: 71MI21EQ |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO FRESENIUS HEMOCARE BRASIL LTDA CNPJ 49601107000184 RUA ROQUE GONZALEZ 128 ITAPECERICA DA SERRA SP TEL 11 2504 1481 EMAIL CINTIAGARCIAFRESENIUSKABICOM FABRICANTE DO PRODUTO FRESENIUS HEMOCARE BRASIL LTDA RUA ROQUE GONZALEZ 128 BRASIL |
| Models | 10154450145, 71MI21EQ |
| Date | Oct 25, 2018 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
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