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

Source: https://www.globalkeysolutions.net/records/china_product_recall/ortho-clinical-diagnostics-inc/4fcb4d80-5669-4554-b190-da56d2e9b45b/
Source feed: China

> China NMPA product recall for Lithium determination using dry slides (colorimetric method) by Ortho-Clinical Diagnostics, Inc. published April 10, 2017. Recall level: Level II. Ausendo Medical Devices Trading (China) Co., Ltd., in conjunction with manufacturer Ortho-Clinical D

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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: 2017-04-10
- 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 the entire dry sheet or consecutive dry sheets within the dry sheet cassette.
- Discovering Company: Orsendo Medical Equipment Trading (China) Co., Ltd.
- Manufacturing Company: Ortho-Clinical Diagnostics, Inc.
- Summary: Ausendo Medical Devices Trading (China) Co., Ltd., in conjunction with manufacturer Ortho-Clinical Diagnostics, Inc., initiated a voluntary Class II recall of two specific batches of Lithium Assay Dry Tablets (Colorimetric Method) on April 10, 2017. The recall was prompted by the discovery that these batches could produce intermittent result bias, affecting entire dry sheets or consecutive sheets within a box, rather than isolated instances. The affected products were imported globally, with 3 boxes of batch 8318925 sold in China. This action was reported to the National Medical Products Administration (NMPA), China's regulatory authority for medical devices. As a required action, distributors were instructed to immediately cease distribution and discard all remaining stock of the problematic batches. Ausendo Medical Devices Trading (China) Co., Ltd. committed to providing replacements for all affected products.

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