International safety notice
Alert 2967 2nd Update (Technosurveillance) - Roche - MYO2, Tina-Quant Myoglobin Gen.2 Possibility of sporadic inaccuracy of quality controls (QCs) and calibration failures with the Tina-quant Myoglobin Gen.2 (MYO2) assay.
Brazil / Anvisa · BRA · Aug 22, 2019
Key facts
| Title | Alert 2967 2nd Update (Technosurveillance) - Roche - MYO2, Tina-Quant Myoglobin Gen.2 Possibility of sporadic inaccuracy of quality controls (QCs) and calibration failures with the Tina-quant Myoglobin Gen.2 (MYO2) assay. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Commercial name: MYO2, Tina-Quant Myoglobin Gen.2. Technical Name: Myoglobin. ANVISA registration number: 10287410619. Product type: Diagnostic product for in vitro use. Risk Class: II. Affected model: 100 tests (R1: 9mL / R2: 3mL). Affected serial numbers: Product Code: 04580010190 / Lots: 14701301; Reason for the second update: inclusion of the third version of the Alert Message (Letter to the Customer). Access the full content of Alert 2967 with the respective annexes on the ANVISA Portal (http://portal.anvisa.gov.br/alertas). |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO ROCHE DIAGNÓSTICA BRASIL LTDA CNPJ 30280358000186 AVENIDA ENGENHEIRO BILLINGS 1729 PRÉDIO 38 SÃO PAULO SP TEL 11 37198464 EMAIL BRASILTECNOVIGILANCIAROCHECOM FABRICANTE DO PRODUTO ROCHE DIAGNOSTICS GMBH SANDHOFER STRASSE 116 68305 ALEMANHA |
| Models | 61833001, 10287410619, 25244001, 20168601, 60854501, Gen.2, 04580010190, 32132701, 14701301 |
| Date | Aug 22, 2019 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
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