International safety notice
Alert 2788 (Technosurveillance) - Agilent Technologies Brasil Ltda - Autostainer Link 48, Autostainer Plus Link - Possibility of failure causing false negative results.
Brazil / Anvisa · BRA · Jan 28, 2019
Key facts
| Title | Alert 2788 (Technosurveillance) - Agilent Technologies Brasil Ltda - Autostainer Link 48, Autostainer Plus Link - Possibility of failure causing false negative results. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Nome Comercial: Autostainer Link 48; Autostainer Plus Link Technical Name: Instrument for sample preparation and processing pre-analytical phase ANVISA registration number: 80000230068 Risk Class: I Affected model: AS48030; Affected serial numbers: AS1631D1005, AS2813D1302, AS1510D0910, AS1166F1006, AS3001D1307, AS1711D1008, AS1676D1007, AS1704D1008, AS1617D1005, AS1113F1001, AS3003D 1307, AS1625D1005, AS1095F0911, AS3323D1403, AS3316D1403, S38-7753-01, AS3306D1403, AS3731D1410, AS1771D1010, AS2814D1302, AS1400D0908 , AS1670D1007, AS3270D1402, AS3281D1402, AS3333D1403, AS3297D1402, AS3282D1402, AS1701D1008, AS1049D0811, S38-0337-01, AS2603D1209, AS1486D091 0, AS1541D1001, AS3308D1403, S38-0555-01, AS3330D1403, AS3314D1403, AS1733D1009, AS1049D08, AS1731D1009, AS3317D1403, AS3320D1403 , AS1050D0811, AS2852D1303, AS330D1403, AS3329D1403, AS285D1303, AS5285D1303. |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO AGILENT TECHNOLOGIES BRASIL LTDA CNPJ 03290250000100 AVENIDA MARCOS PENTEADO DE ULHOA RODRIGUES 939 ANDAR 6 SALA B BARUERI SÃO PAULO TEL 11 4197 3713 EMAIL VANESSAFONSECAAGILENTCOM FABRICANTE DO PRODUTO DAKO NORTH AMÉRICA INC 6392 VIA REAL ESTADOS UNIDOS |
| Models | AS3306D1403, AS1400D0908, AS1486D0910, AS3003D1307, AS1617D1005, AS1049D08, AS1631D1005, AS2603D1209, AS3333D1403, AS1676D1007, AS5285D1303, AS3316D1403 and 39 more |
| Date | Jan 28, 2019 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
- 10–99 Matching device models in FDA data
- 10–99 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