International safety notice
Alerta 2965 (Tecnovigilância) - Beckman Coulter - Access Free T3, Access Total T3, Access Free T4, Access GI Monitor, Access Thyroglobulin, Access Thyroglobulin Antibody II – Informações sobre interferência da biotina.
Brazil / Anvisa · BRA · Aug 22, 2019
Key facts
| Title | Alerta 2965 (Tecnovigilância) - Beckman Coulter - Access Free T3, Access Total T3, Access Free T4, Access GI Monitor, Access Thyroglobulin, Access Thyroglobulin Antibody II – Informações sobre interferência da biotina. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Nome Comercial: Access Free T3 (registro 10033120567); Access Total T3 (registro 10033120540); Access Free T4 (registro 10033120499); Access GI Monitor (registro 10033120447); ACCESS THYROGLOBULIN (registro 10033120497); Access Thyroglobulin Antibody II (registro 10033120565). Technical Name: Triiodothyronine (T3) Free (registration 10033120567); ANVISA registration number: 10033120567; Risk Class: II and III. Affected model: All. Affected lot numbers: All Access Immunoassay reagent lots listed: Free T3, Total T3, Free T4, GI Monitor, Thyroglobulin and Thyroglobulin Antibody II. |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO BECKMAN COULTER DO BRASIL COMÉRCIO E IMPORTAÇÃO DE PRODUTOS DE LABORATÓRIO LTDA CNPJ 42160812000144 AL RIO NEGRO 500 TORRE B 15º ANDAR ALPHAVILLE INDUSTRIAL BARUERI SP TEL 11 41548813 EMAIL DMWOLINGERBECKMANCOM FABRICANTE DO PRODUTO BECKMAN COULTER INC 250 SOUTH KRAEMER BOULEVARD 92821 BREA ESTADOS UNIDOS DA AMÉRICA |
| Models | 10033120565, 10033120499, 10033120497, 10033120540, 10033120567, 10033120447 |
| Date | Aug 22, 2019 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
- 1–9 Matching device models 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