International safety notice
Alert 2562 (Technosurveillance) Updated through Alert 2926 - Roche - Elecsys Vitamin D total II Possibility of falsely elevated results.
Brazil / Anvisa · BRA · May 4, 2018
Key facts
| Title | Alert 2562 (Technosurveillance) Updated through Alert 2926 - 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: N/A Affected Lot/Series Numbers: Elecsys Vitamin D total II (100 tests) (Code: 7464215190 and Registration: 10287411273) lots at risk in Brazil: 27398201 / 29822801 / 27398202 Elecsys Vitamin D total II (300 tests) (Code: 7028148190 and Registration: 10287411242) lots at risk in Brazil: 23010601 / 27396201 |
| 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 | 23010601, 27398201, 10287411242, 10287411273, 7028148190, 27398202, 27396201, 29822801, 7464215190 |
| Date | May 4, 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