# China NMPA Product Recall - Lipase Assay Kit (Dry Chemistry Rate Method)

Source: https://www.globalkeysolutions.net/records/china_product_recall/ortho-clini-diagnostics-inc-usa/5db7e4d3-3c6a-414c-bace-22ce18164012/
Source feed: China

> China NMPA product recall for Lipase Assay Kit (Dry Chemistry Rate Method) by Ortho-Clini Diagnostics, Inc. (USA) published October 07, 2023. Recall level: Level 2 Recall. The National Medical Products Administration (NMPA) announced a voluntary product recall initiated b

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Ortho-Clinical Diagnostics, Inc. is voluntarily recalling its lipase assay kit (dry chemical rate method).
- Company Name: Ortho-Clini Diagnostics, Inc. (USA)
- Publication Date: 2023-10-07
- Product Name: Lipase Assay Kit (Dry Chemistry Rate Method)
- Recall Level: Level 2 Recall
- Recall Reason: Some batches of lipase assay kits (dry chemical rate method) may contain abnormal continuous lipase assay strips, which may lead to inaccurate test results.
- Discovering Company: Orsendo Medical Equipment Trading (China) Co., Ltd.
- Manufacturing Company: Ortho-Clini Diagnostics, Inc. (USA)
- Summary: The National Medical Products Administration (NMPA) announced a voluntary product recall initiated by Ortho-Clinical Diagnostics, Inc., effective October 7, 2023. The recall specifically targets certain batches of their Lipase Assay Kits (dry chemical rate method), identified as VITROS Chemistry Products LIP/ under Medical Device Registration Certificate No. 20152402810. The manufacturer reported that these kits might contain abnormal continuous lipase assay dry strips, which poses a risk of causing adverse reactions. As a result, Ortho-Clinical Diagnostics, Inc. is voluntarily recalling the affected products. This action falls under the NMPA's regulatory framework and has been designated as a Level II recall, signifying a situation where the use of, or exposure to, the product may lead to temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. Further specifics on the affected product models, specifications, and batches are detailed in the accompanying 'Medical Device Recall Event Report Form' submitted by Ausendo Medical Device Trading (China) Co., Ltd.

Company: https://www.globalkeysolutions.net/companies/ortho-clini-diagnostics-inc-usa/1882e70e-4aa3-4181-8c65-f133f4a168d7/