International safety notice
Alert 2926 (Technovigilance) Roche - Elecsys Vitamin D total II Possibility of falsely elevated results.
Brazil / Anvisa · BRA · Jul 19, 2019
Key facts
| Title | Alert 2926 (Technovigilance) Roche - Elecsys Vitamin D total II Possibility of falsely elevated results. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Commercial name: Elecsys Vitamin D total II Technical name: Vitamin D ANVISA registration number: 10287411273; Risk class: II Affected model: Elecsys Vitamin D total II (100 tests) (Code: 7464215190 and Registration: 10287411273); Affected Lot/Series Numbers: See attachment List of lots at risk |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO ROCHE DIAGNÓSTICA BRASIL LTDA CNPJ 30280358000186 AVENIDA ENGENHEIRO BILLINGS 1729 PRÉDIO 38 SÃO PAULO SP TEL 11 37198464 EMAIL PAULABRESCIANIROCHECOM FABRICANTE ROCHE DIAGNOSTICS GMBH SANDHOFER STRASSE 116 68305 ALEMANHA |
| Models | 7464215190, 7028148190, 10287411242, 10287411273 |
| Date | Jul 19, 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