# China NMPA Product Recall - Lithium determination using dry slides (colorimetric method)

Source: https://www.globalkeysolutions.net/records/china_product_recall/ortho-clinical-diagnostics-inc/8575d348-8d2d-4511-9053-087462ca5f98/
Source feed: China

> China NMPA product recall for Lithium determination using dry slides (colorimetric method) by Ortho-Clinical Diagnostics, Inc. published April 06, 2017. Recall level: Class II Recall. Ausendo Medical Devices Trading (China) Co., Ltd., collaborating with manufacturer Ortho-Clinical Di

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Orsendo Medical Devices Trading (China) Co., Ltd. is voluntarily recalling lithium assay dry strips (colorimetric method).
- Company Name: Ortho-Clinical Diagnostics, Inc.
- Publication Date: 2017-04-06
- Product Name: Lithium determination using dry slides (colorimetric method)
- Recall Level: Class II Recall
- Recall Reason: Using two batches of lithium to determine dry sheets (colorimetric method) may introduce intermittent result bias. When this occurs, the inaccuracy does not affect a random individual dry sheet, but it will affect consecutive dry sheets within or between dry sheet cassettes.
- Discovering Company: Orsendo Medical Equipment Trading (China) Co., Ltd.
- Manufacturing Company: Ortho-Clinical Diagnostics, Inc.
- Summary: Ausendo Medical Devices Trading (China) Co., Ltd., collaborating with manufacturer Ortho-Clinical Diagnostics, Inc., initiated a voluntary Class II recall for specific batches of its Lithium Assay Dry Tablets (Colorimetric Method). This action was reported on February 20, 2017, and subsequently published by the National Medical Products Administration (NMPA) on April 6, 2017. The primary concern identified was an intermittent result bias affecting two batches, 3124-0108-6568 and 3124-0108-6569. These tablets are critical for the quantitative determination of lithium in serum and plasma. The inaccuracy was noted to affect consecutive tablets, potentially impacting diagnostic reliability. While one affected product (1632660) had no units imported or sold in China, three boxes of product 8318925 were imported and sold. The recall's scope is global. Under the NMPA's classification, a Class II recall indicates a situation where product use may cause temporary or reversible adverse health consequences, or where serious consequences are remote. As required actions, distributors were instructed to immediately halt distribution and discard all remaining stock of the affected batches. Ausendo Medical Devices Trading (China) Co., Ltd. pledged to provide replacement products, ensuring the integrity and accuracy of diagnostic testing.

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