# China NMPA Product Recall - Total bilirubin assay kit (colorimetric method); Direct bilirubin assay kit (vanadate oxidation method); Total bilirubin assay kit (vanadate oxidation method)

Source: https://www.globalkeysolutions.net/records/china_product_recall/siemens-medical-diagnostics-products-shanghai-co-ltd/77c5d39f-36ea-4b33-85da-4830d51a0418/
Source feed: China

> China NMPA product recall for Total bilirubin assay kit (colorimetric method); Direct bilirubin assay kit (vanadate oxidation method); Total bilirubin assay kit (vanadate oxidation method) by Siemens Medical Diagnostics Products (Shanghai) Co., Ltd. published February 20, 2020. Recall level: Level 3 Recall. Siemens Medical Diagnostics Products (Shanghai) Co., Ltd. initiated a voluntary Class III recall of 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Siemens Medical Diagnostics Products (Shanghai) Co., Ltd. is voluntarily recalling its Total Bilirubin Assay Kit (Colorimetric Method), Direct Bilirubin Assay Kit (Vanadate Oxidation Method), and Total Bilirubin Assay Kit (Vanadate Oxidation Method).
- Company Name: Siemens Medical Diagnostics Products (Shanghai) Co., Ltd.
- Publication Date: 2020-02-20
- Product Name: Total bilirubin assay kit (colorimetric method); Direct bilirubin assay kit (vanadate oxidation method); Total bilirubin assay kit (vanadate oxidation method)
- Recall Level: Level 3 Recall
- Recall Reason: For patients taking eltrombopag, the results from total bilirubin assay kits (colorimetric method), direct bilirubin assay kits (vanadate oxidation method), and total bilirubin assay kits (vanadate oxidation method) may be inconsistent.
- Discovering Company: Siemens Medical Diagnostics Products (Shanghai) Co., Ltd.
- Manufacturing Company: Siemens Medical Diagnostics Products (Shanghai) Co., Ltd.
- Summary: Siemens Medical Diagnostics Products (Shanghai) Co., Ltd. initiated a voluntary Class III recall of several bilirubin assay kits, as announced on February 20, 2020. The affected products include the Total Bilirubin Assay Kit (Colorimetric Method), Direct Bilirubin Assay Kit (Vanadate Oxidation Method), and Total Bilirubin Assay Kit (Vanadate Oxidation Method). This action was taken due to identified issues specifically impacting patients who are taking the medication eltrombopag. The recall was reported following a directive from the Shanghai Food and Drug Administration, under the oversight of the National Medical Products Administration (NMPA) and the Shanghai Municipal Drug Administration. Details regarding the specific models, specifications, and batches involved are available in the accompanying "Medical Device Recall Event Report Form." This proactive measure ensures patient safety and compliance with medical device regulations by addressing the product's performance concerns in a specific patient population.

Company: https://www.globalkeysolutions.net/companies/siemens-medical-diagnostics-products-shanghai-co-ltd/deadd648-fc6f-4bb3-90c6-57b16497a6e9/