International safety notice
Alert 2829 (Technovigilance) - Beckman Coulter do Brasil Comércio e Importação de Produtos de Laboratório Ltda - Access Thyroglobulin Antibody II Calibrators Possibility of falsely reduced results in specific batches.
Brazil / Anvisa · BRA · Mar 22, 2019
Key facts
| Title | Alert 2829 (Technovigilance) - Beckman Coulter do Brasil Comércio e Importação de Produtos de Laboratório Ltda - Access Thyroglobulin Antibody II Calibrators Possibility of falsely reduced results in specific batches. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Nome Comercial: Access Thyroglobulin Antibody II Calibrators Technical Name: Thyroglobulin (Tg) ANVISA registration number: 10033120557 Risk Class: II Affected model: 6 bottles: 1 x 4ml (S0), 5 x 2.5ml (S1-S5) Affected serial numbers: Product A32898 - Lots: 832055; |
| 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 928216232 BREA ESTADOS UNIDOS DA AMÉRICA |
| Models | A32898, 83163, 832055, 10033120557, 831759, 831710, S1-S5 |
| Date | Mar 22, 2019 |
| 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