# China NMPA Product Recall - Neonatal bilirubin assay using dry slides (colorimetric method)

Source: https://www.globalkeysolutions.net/records/china_product_recall/ortho-clinical-diagnostics-inc/50f6f081-d2e7-4a2e-8ae5-2adb527a945e/
Source feed: China

> China NMPA product recall for Neonatal bilirubin assay using dry slides (colorimetric method) by Ortho-Clinical Diagnostics, Inc. published January 19, 2012. Recall level: . The National Medical Products Administration (NMPA) published a notice on January 19, 2012, regardin

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Ortho Clinical Diagnostics, Inc. of the United States has recalled neonatal bilirubin assay dry strips (colorimetric method).
- Company Name: Ortho-Clinical Diagnostics, Inc.
- Publication Date: 2012-01-19
- Product Name: Neonatal bilirubin assay using dry slides (colorimetric method)
- Recall Reason: Results from neonatal bilirubin assays using the DT calibration kit (Lot37) and dry slides (GEN72) may be biased.
- Discovering Company: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd.
- Manufacturing Company: Ortho-Clinical Diagnostics, Inc.
- Summary: The National Medical Products Administration (NMPA) published a notice on January 19, 2012, regarding a global voluntary recall initiated by Ortho Clinical Diagnostics, Inc. This recall concerns specific models of its Neonatal Bilirubin Assay Dry Strips (Colorimetric Method), which are used for quantitative total bilirubin determination in newborn serum and plasma. The primary issue identified was the potential for discrepancies or biases in results when using GEN72 generation dry tablets with the DT calibration kit (Lot37). Johnson & Johnson (Shanghai) Medical Devices Co., Ltd., the responsible unit in China, confirmed that no affected batches of these products were imported into or sold within the Chinese market. Consequently, the manufacturer deemed specific corrective actions, such as product retrieval, not applicable for China. Despite the absence of direct sales in China, the NMPA's regulatory framework prompted a directive for provincial, autonomous region, and municipal food and drug administrations to enhance their supervision and management over similar medical products, ensuring continued public health oversight.

Company: https://www.globalkeysolutions.net/companies/ortho-clinical-diagnostics-inc/1aeceeb0-508e-4f89-ae53-22ef3ba7bd86/