# China NMPA Product Recall - Myoglobin Assay Kit (Immunoturbidimetric Assay) Tina-quant Myoglobin Gen.2 (MYO2)

Source: https://www.globalkeysolutions.net/records/china_product_recall/roche-diagnostics-gmbh/83b5d845-a5e0-45d2-9984-a3ee7eb41b79/
Source feed: China

> China NMPA product recall for Myoglobin Assay Kit (Immunoturbidimetric Assay) Tina-quant Myoglobin Gen.2 (MYO2) by Roche Diagnostics GmbH published November 16, 2021. Recall level: . Roche Diagnostics GmbH, with its subsidiary Roche Diagnostics Products (Shanghai) Co., Ltd., announc

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Roche Diagnostics GmbH is voluntarily recalling its Tina-quant Myoglobin Gen.2 (MYO2) myoglobin assay kit (immunoturbidimetric method).
- Company Name: Roche Diagnostics GmbH
- Publication Date: 2021-11-16
- Product Name: Myoglobin Assay Kit (Immunoturbidimetric Assay) Tina-quant Myoglobin Gen.2 (MYO2)
- Recall Reason: Myoglobin assay kits exhibited negative bias in quality control and monitoring results on the Cobas C503 platform.
- Discovering Company: Roche Diagnostics Products (Shanghai) Co., Ltd.
- Manufacturing Company: Roche Diagnostics GmbH
- Summary: Roche Diagnostics GmbH, with its subsidiary Roche Diagnostics Products (Shanghai) Co., Ltd., announced a voluntary recall for specific models and batches of its Tina-quant Myoglobin Gen.2 (MYO2) Myoglobin Assay Kit (Immunoturbidimetric Assay). This recall, publicly reported on November 16, 2021, was initiated due to a critical quality concern: the kit exhibited a negative bias in quality control and monitoring results when utilized on the cobas c503 platform. This performance deviation indicates that the assay may inaccurately report myoglobin levels, potentially impacting patient diagnosis and treatment decisions, given myoglobin's role as a cardiac biomarker. The National Medical Products Administration (NMPA) in China published this recall, serving as the primary regulatory body overseeing medical device safety and efficacy. As a required action, Roche Diagnostics GmbH is conducting a voluntary recall of the affected product, Registration Certificate No.: 20162400540. While the precise recall level was not specified, the company is ensuring all relevant details regarding the affected product models, specifications, and batch numbers are accessible through the 'Medical Device Recall Event Report Form' to facilitate proper action by users.

Company: https://www.globalkeysolutions.net/companies/roche-diagnostics-gmbh/2a33a337-c39d-4329-b659-c812f690f94b/