International safety notice
Alert 2652 (Technovigilance) - Abbott Laboratórios do Brasil Ltda - Architect System - Possibility of generating incorrect results if the pressure monitoring system is not activated.
Brazil / Anvisa · BRA · Aug 23, 2018
Key facts
| Title | Alert 2652 (Technovigilance) - Abbott Laboratórios do Brasil Ltda - Architect System - Possibility of generating incorrect results if the pressure monitoring system is not activated. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade Name: Architect System Technical Name: Instrument intended for immunoassays ANVISA registration number: 80146501938 Risk Class: II Affected model: c8000, C4000 and c16000 Affected serial numbers: C400144, C400731, C401327, C401390, C401483, c401905, C460119, C460146, C460475, C460476, C460478, C460479, C460511, C460513, C460 514, C460518, C460530, C460556, C460580, c460668, C460693, C460696, C460772 , C461174, C803000, C400582, C803378, C803379, C460255, C460577, C460621, C460622, C460624, C460638, C460639, C460700, C460771, C460894, C460897, C460898, C460899, C460901, C460902, C460903, C460904, C460905, C460906, C460907 , C460963, C460964, C803580, C461115, C804007, C804217, c400550, C401701, C401835, C401944, C460123, C460436, C460474, C460803, C461215, C402169, C400878, C460266, C460852, C460853, C460909, C400877, C400951, C401069, C401072 , C401073, C460531, C460582, C460598, C460746, C460750, C803283, C401351, C460221, C460687, C460477, C460512, C460581, C401391, C401702, C401781, C401834, C401936, C401943, c460666, C1600198, C460480, C460756, C1600831, C1600832 , c460133, C460481, C460521, C460669, C460867, C460911, C461116, C461214, C803259, C803260, C803952. |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO ABBOTT LABORATÓRIOS DO BRASIL LTDA CNPJ 56998701000116 RUA MICHIGAN 735 CIDADE MONÇÕES SÃO PAULO SP TEL 55 11 5536 7356 EMAIL CAMILAFERREIRAABBOTTCOM FABRICANTE DO PRODUTO ABBOTT LABORATORIES DIAGNOSTICS DIVISION 100 ABBOTT PARK ROAD ABBOTT PARK ILLINOIS 60064 USA ESTADOS UNIDOS |
| Models | C460475, C460693, C460902, C460530, C460598, C401073, C400951, C401390, C460511, C401834, C460621, C460963 and 101 more |
| Date | Aug 23, 2018 |
| 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