# China NMPA Product Recall - Glucose assay dry strips (colorimetric method); Lactic acid assay dry strips (colorimetric method); Triglyceride assay dry strips (colorimetric method); Uric acid assay dry strips (colorimetric method)

Source: https://www.globalkeysolutions.net/records/china_product_recall/ortho-clinical-diagnostics-tc2016-196/7d654c82-9660-434a-9fee-f62dcf1bafd7/
Source feed: China

> China NMPA product recall for Glucose assay dry strips (colorimetric method); Lactic acid assay dry strips (colorimetric method); Triglyceride assay dry strips (colorimetric method); Uric acid assay dry strips (colorimetric method) by Ortho-Clinical Diagnostics (TC2016-196) published December 07, 2016. Recall level: Level II. Ausendo Medical Devices Trading (China) Co., Ltd., representing Ortho-Clinical Diagnostics, initiate

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Orsendo Medical Devices Trading (China) Co., Ltd. is voluntarily recalling its glucose assay tablets, lactate assay tablets, triglyceride assay tablets, and uric acid assay tablets (colorimetric method).
- Company Name: Ortho-Clinical Diagnostics (TC2016-196)
- Publication Date: 2016-12-07
- Product Name: Glucose assay dry strips (colorimetric method); Lactic acid assay dry strips (colorimetric method); Triglyceride assay dry strips (colorimetric method); Uric acid assay dry strips (colorimetric method)
- Recall Level: Level II
- Recall Reason: N-acetylcysteine (NAC) may interfere with certain VITROS Chemistry Products assays and may lead to biased sample results in patients given NAC. Additionally, dextran 40 and glutathione may also interfere with existing glucose assays (colorimetric methods).
- Discovering Company: Orsendo Medical Equipment Trading (China) Co., Ltd.
- Manufacturing Company: Ortho-Clinical Diagnostics (TC2016-196)
- Summary: Ausendo Medical Devices Trading (China) Co., Ltd., representing Ortho-Clinical Diagnostics, initiated a Class II voluntary recall on December 7, 2016, following an internal report from October 9, 2016. This action, under the National Medical Products Administration (NMPA) framework, addresses significant interference issues identified with several in-vitro diagnostic products. The affected items include Glucose Assay Dry Tablets, Lactate Assay Dry Tablets, Triglyceride Assay Dry Tablets, and Uric Acid Assay Dry Tablets (Colorimetric Method).

The core issue is potential interference from N-acetylcysteine (NAC) with the chemical reagents in these dry tablets, leading to biased patient sample results. Furthermore, dextran 40 and glutathione were found to interfere with the glucose assay dry tablets. While continued use of the affected products is considered acceptable, corrective actions are required. These include revising product instructions to explicitly warn that samples from patients treated with NAC, dextran 40, or glutathione may yield inaccurate results, necessitating adherence to established laboratory procedures for known assay interferences. All impacted customers will receive formal notification regarding these critical updates.

Company: https://www.globalkeysolutions.net/companies/ortho-clinical-diagnostics-tc2016-196/3fce0c14-c724-4647-a932-593127fb93e8/