# China NMPA Product Recall - Amylase assay using dry slides (rate method)

Source: https://www.globalkeysolutions.net/records/china_product_recall/ortho-clinical-diagnostics-inc/c1c629d5-71a1-4564-8766-9fc1bf0e8bdc/
Source feed: China

> China NMPA product recall for Amylase assay using dry slides (rate method) by Ortho-Clinical Diagnostics, Inc. published June 04, 2020. Recall level: Level 2 Recall. On June 4, 2020, Ortho-Clinical Diagnostics (China) Co., Ltd., acting on behalf of Orsendo Clinical 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Orsendo Medical Devices Trading (China) Co., Ltd. is voluntarily recalling amylase assay dry tablets (rate method).
- Company Name: Ortho-Clinical Diagnostics, Inc.
- Publication Date: 2020-06-04
- Product Name: Amylase assay using dry slides (rate method)
- Recall Level: Level 2 Recall
- Recall Reason: Due to observed imprecision when using product amylase assay dry tablets (rate method) for quality control and patient samples, and the discovery that some laboratories' quality control solution record data analysis showed standard deviations higher than the estimated in-laboratory standard deviations in the VITROS quality control test sheets, problems were found.
- Discovering Company: Orsendo Medical Equipment Trading (China) Co., Ltd.
- Manufacturing Company: Ortho-Clinical Diagnostics, Inc.
- Summary: On June 4, 2020, Ortho-Clinical Diagnostics (China) Co., Ltd., acting on behalf of Orsendo Clinical Diagnostics (USA) Inc., announced a voluntary Class II recall of its Amylase Assay Dry Tablets (Rate Method). The decision stemmed from observed imperfections in the product's performance when used for quality control and patient sample analysis. Specifically, investigations revealed that standard deviations exceeded the estimated intra-laboratory standard deviations in VITROS quality control test sheets at some facilities, indicating potential reliability concerns. This recall falls under the regulatory purview of the National Medical Products Administration (NMPA) of China, with the announcement originating from the Shanghai Municipal Drug Administration website. The NMPA's framework mandates such actions to safeguard public health and ensure the reliability of medical devices. The primary required action by the company is the immediate withdrawal of the affected product from the market. Comprehensive details concerning the specific product models, specifications, and batch numbers involved are provided in the associated 'Medical Device Recall Event Report Form' to facilitate proper handling and compliance.

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