International safety notice
Alert 2640 (Technosurveillance) - Werfen Medical Ltda.
Brazil / Anvisa · BRA · Aug 9, 2018
Key facts
| Title | Alert 2640 (Technosurveillance) - Werfen Medical Ltda. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Nome Comercial: HemosIL ReadiPlasTin Technical Name: Prothrombin Time (PT) ANVISA registration number: 80003610530 Risk Class: III Modelo afetado: ReadiPlasTin Reagent: 5 x 0.5 mL, ReadiPlasTin Diluent: 5 x 9.5 mL Affected serial numbers: N0278177 (20 units) |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO WERFEN MEDICAL LTDA CNPJ 02004662000165 ESTRADA DOS ROMEIROS KM 385 CONDOMÍNIO MORRO GRANDE MÓD G9 N 138 SANTANA DE PARNAÍBA SP TEL 11 46227878 EMAIL EURIDIANAGARCIAWERFENCOM FABRICANTE DO PRODUTO INSTRUMENTATION LABORATORY 180 HARTWELL ROAD BEDFORD MA 017302443 ESTADOS UNIDOS DA AMÉRICA |
| Models | N0278177, 80003610530 |
| Date | Aug 9, 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