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

Source: https://www.globalkeysolutions.net/records/china_product_recall/ortho-clinical-diagnostics-inc/1478248b-ef23-47d5-b22c-fb07c078d48f/
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. Ausendo Medical Devices Trading (China) Co., Ltd., in coordination with manufacturer Ortho-Clinical 

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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: Ausendo Medical Devices Trading (China) Co., Ltd., in coordination with manufacturer Ortho-Clinical Diagnostics, Inc., initiated a Class III recall for their Urine Protein Assay Dry Strips (Colorimetric Method). The recall was prompted by the discovery of biased measurement results when using the product, posing a risk to accurate diagnostic testing. This action, reported to the National Medical Products Administration (NMPA) on January 4, 2017, and published on February 21, 2017, impacts 4320 boxes globally, with 3109 boxes sold in China, across various identified batch numbers. To address the issue, Ortho-Clinical Diagnostics, Inc. is required to notify all affected customers, advise them to carefully monitor the results of the strips they are currently using, and promptly replace the faulty product batches with new ones. This ensures patient safety and diagnostic reliability under the NMPA's regulatory framework.

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