# China NMPA Product Recall - Albumin Gen.2 (ALB2) Assay Kit (Colorimetric Method); Total Bilirubin Assay Kit (Diazo Method)

Source: https://www.globalkeysolutions.net/records/china_product_recall/roche-diagnostics-products-shanghai-co-ltd/0716f53b-089d-4085-812b-ae0c1272fc59/
Source feed: China

> China NMPA product recall for Albumin Gen.2 (ALB2) Assay Kit (Colorimetric Method); Total Bilirubin Assay Kit (Diazo Method) by Roche Diagnostics Products (Shanghai) Co., Ltd. published January 16, 2020. Recall level: Level 2 Recall. Roche Diagnostics Products (Shanghai) Co., Ltd. initiated a voluntary Level II recall of specific ba

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Roche Diagnostics Products (Shanghai) Co., Ltd. is voluntarily recalling its Albumin Gen.2 (ALB2) Assay Kit (Colorimetric Method) and Total Bilirubin Assay Kit (Diazo Method).
- Company Name: Roche Diagnostics Products (Shanghai) Co., Ltd.
- Publication Date: 2020-01-16
- Product Name: Albumin Gen.2 (ALB2) Assay Kit (Colorimetric Method); Total Bilirubin Assay Kit (Diazo Method)
- Recall Level: Level 2 Recall
- Recall Reason: Some batches of albumin and total bilirubin assay kits showed low quality control recoveries exceeding laboratory acceptable limits on the Cobas C701/702 platform.
- Discovering Company: Roche Diagnostics Products (Shanghai) Co., Ltd.
- Manufacturing Company: Roche Diagnostics Products (Shanghai) Co., Ltd.
- Summary: Roche Diagnostics Products (Shanghai) Co., Ltd. initiated a voluntary Level II recall of specific batches of its Albumin Gen.2 (ALB2) and Total Bilirubin Assay Kits (Diazo Method). This action, initially reported to the National Medical Products Administration (NMPA) and the Shanghai Drug Administration on October 18, 2019, and publicly updated on January 16, 2020, stems from critical quality control issues. The company received complaints regarding low quality control recoveries for albumin test kit batches 33962301 and 36133801 when utilized on the cobas c701/702 platform, with results exceeding acceptable laboratory limits. A subsequent investigation by Roche Diagnostics headquarters confirmed that an additional batch, 37437301, is also affected. Importantly, these kits performed correctly on other platforms, including cobas c311/501/502, COBAS INTEGRA 400 plus, and cobas c503, indicating a platform-specific issue. The recall is conducted under the NMPA regulatory framework, with comprehensive details regarding affected product models, specifications, and batches provided in the accompanying "Medical Device Recall Event Report Form." This voluntary recall ensures product safety and compliance with established regulatory standards.

Company: https://www.globalkeysolutions.net/companies/roche-diagnostics-products-shanghai-co-ltd/9b830c5b-8305-4f55-9e76-759151e7c7a9/