# China NMPA Product Recall - Total bilirubin determination dry slides (colorimetric method); conjugated and unconjugated bilirubin determination dry slides (dual-wavelength colorimetric method)

Source: https://www.globalkeysolutions.net/records/china_product_recall/orsendo-medical-equipment-trading-china-co-ltd/498a1b09-4a46-40e1-bfc6-ed058cd54c49/
Source feed: China

> China NMPA product recall for Total bilirubin determination dry slides (colorimetric method); conjugated and unconjugated bilirubin determination dry slides (dual-wavelength colorimetric method) by Orsendo Medical Equipment Trading (China) Co., Ltd. published August 28, 2020. Recall level: Level 2 Recall. Ausendo Medical Devices Trading (China) Co., Ltd. initiated a voluntary Class II recall of its Total

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Orsendo Medical Devices Trading (China) Co., Ltd. is voluntarily recalling dry tablets for total bilirubin determination (colorimetric method) and conjugated and unconjugated bilirubin determination (dual-wavelength colorimetric method).
- Company Name: Orsendo Medical Equipment Trading (China) Co., Ltd.
- Publication Date: 2020-08-28
- Product Name: Total bilirubin determination dry slides (colorimetric method); conjugated and unconjugated bilirubin determination dry slides (dual-wavelength colorimetric method)
- Recall Level: Level 2 Recall
- Recall Reason: The product in question may interfere with the results of specific total bilirubin assays (colorimetric method) and conjugated and unconjugated bilirubin assays (dual-wavelength colorimetric method) due to the presence of eltrombopag (drug).
- Discovering Company: Orsendo Medical Equipment Trading (China) Co., Ltd.
- Manufacturing Company: Orsendo Medical Equipment Trading (China) Co., Ltd.
- Summary: Ausendo Medical Devices Trading (China) Co., Ltd. initiated a voluntary Class II recall of its Total Bilirubin Determination Tablets (Colorimetric Method) and Conjugated and Unconjugated Bilirubin Determination Tablets (Dual Wavelength Colorimetric Method). This action, reported by the Shanghai Drug Administration and published by the National Medical Products Administration (NMPA) on August 28, 2020, addresses a critical product performance issue. The primary concern is the potential interference of the drug eltrombopag with the measurement results obtained from these specific bilirubin assay dry tablets. This interference could lead to inaccurate diagnostic readings for patients. The regulatory framework governing this recall falls under the authority of the NMPA, with the Shanghai Drug Administration reporting the company's notification. The required action involves retrieving the affected products from the market to mitigate risks associated with inaccurate bilirubin measurements, which are crucial for patient diagnosis and treatment. Specific models and batches are detailed in an accompanying Medical Device Recall Event Report Form.

Company: https://www.globalkeysolutions.net/companies/orsendo-medical-equipment-trading-china-co-ltd/9d283785-b2ea-4291-8250-5927daf06726/