# China NMPA Product Recall - Urine protein assay dry slide (colorimetric method)

Source: https://www.globalkeysolutions.net/records/china_product_recall/ortho-clinical-diagnostics-inc/0aa6780c-3d4a-4823-a2be-9af8ac7f45bc/
Source feed: China

> China NMPA product recall for Urine protein assay dry slide (colorimetric method) by Ortho-Clinical Diagnostics, Inc. published February 21, 2017. Recall level: Level 3 Recall. The National Medical Products Administration (NMPA) issued a recall notice on February 21, 2017, for

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Orsendo Medical Devices Trading (China) Co., Ltd. is voluntarily recalling its urine protein assay dry strips (colorimetric method).
- Company Name: Ortho-Clinical Diagnostics, Inc.
- Publication Date: 2017-02-21
- Product Name: Urine protein assay dry slide (colorimetric method)
- Recall Level: Level 3 Recall
- Recall Reason: There is a potential for biased results when using urine protein assay dry strips (colorimetric method) to measure urine protein.
- Discovering Company: Orsendo Medical Equipment Trading (China) Co., Ltd.
- Manufacturing Company: Ortho-Clinical Diagnostics, Inc.
- Summary: The National Medical Products Administration (NMPA) issued a recall notice on February 21, 2017, for Urine Protein Assay Dry Strips (Colorimetric Method), initiated by Ausendo Medical Devices Trading (China) Co., Ltd. The manufacturer, Ortho-Clinical Diagnostics, Inc., reported a potential bias in the measurement results when the strips were used to determine urine protein content. This issue, initially reported on January 4, 2017, led to a Class III recall. The affected product, registered under National Medical Device Registration Certificate 20152402859, is used for the quantitative determination of urinary protein. Globally, 4320 boxes were impacted, with 3109 boxes sold in China. Corrective actions include notifying all affected customers and advising them to monitor the results of the currently used strips. Ortho-Clinical Diagnostics, Inc. has committed to replacing the affected products with new batches promptly to ensure diagnostic accuracy.

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