International safety notice
Alert 2741 (Technovigilance) - VR Medical - Staclot-LA - Anticoagulant Lupus Detection Kit - Possibility, in specific batches, of shortened results (T1-T2), outside the range specified on the kit value sheet.
Brazil / Anvisa · BRA · Nov 28, 2018
Key facts
| Title | Alert 2741 (Technovigilance) - VR Medical - Staclot-LA - Anticoagulant Lupus Detection Kit - Possibility, in specific batches, of shortened results (T1-T2), outside the range specified on the kit value sheet. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Commercial Name: Staclot-LA - Anticoagulant Lupus Detection Kit Technical Name: Systemic Lupus Erythematosus ANVISA registration number: 80102510327 Risk Class: III Affected model: REF 00600 Affected serial numbers: 251918; |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO VR MEDICAL IMPORTADORA E DISTRIBUIDORA DE PRODUTOS MÉDICOS LTDA CNPJ 04718143000194 RUA BATATAES 391 CONJUNTOS 11 12 E 13 JARDIM PAULISTA SÃO PAULO SP TEL 11989257160 EMAIL CRISTIANEAGUIRREVRMEDICALCOMBR FABRICANTE DO PRODUTO DIAGNOSTICA STAGO SAS FRANÇA ZAC DES CHATAIGNIERS 2329 RUE CONSTANTIN PECQUEUR TAVERNY 95150 |
| Models | 00600, 251918, 80102510327, 252751 |
| Date | Nov 28, 2018 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
- 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