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

Source: https://www.globalkeysolutions.net/records/china_product_recall/ortho-clinical-diagnostics-inc/9fb17e40-26d3-4c8e-a30b-3d7950363838/
Source feed: China

> China NMPA product recall for Lithium determination using dry slides (colorimetric method) by Ortho-Clinical Diagnostics, Inc. published March 17, 2017. Recall level: Level II. Ausendo Medical Devices Trading (China) Co., Ltd. initiated a voluntary Class II recall on February 

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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: 2017-03-17
- Product Name: Lithium determination using dry slides (colorimetric method)
- Recall Level: Level II
- 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. initiated a voluntary Class II recall on February 20, 2017, concerning specific batches of Lithium Assay Dry Tablets (Colorimetric Method). This product, manufactured by Ortho-Clinical Diagnostics, Inc. with Ortho-Clinical Diagnostics Trading (China) Co., Ltd. serving as the responsible unit in China, was found to exhibit an intermittent result bias. The main issue identified was that two affected batches (3124-0108-6568 and 3124-0108-6569) could produce inaccurate results, particularly affecting consecutive tablets within or between cassettes, rather than isolated individual tablets. This could lead to unreliable lithium level determinations in serum and plasma.

Operating under the oversight of the National Medical Products Administration (NMPA), the company implemented immediate corrective actions globally. Affected distributors were instructed to promptly cease further distribution and safely dispose of all remaining stock from the implicated batches. Ausendo Medical Devices Trading (China) Co., Ltd. committed to providing replacement products to mitigate the impact on customers. This decisive action underscores the companies' commitment to product reliability and patient safety by addressing the identified performance inconsistencies.

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