# China NMPA Product Recall - Creatine kinase assay dry slides (rate method)

Source: https://www.keypedia.com/records/china_product_recall/orsendo-medical-equipment-trading-china-co-ltd/409bbca8-7663-45eb-9de5-0479331d31d1
Source feed: China

> China NMPA product recall for Creatine kinase assay dry slides (rate method) by Orsendo Medical Equipment Trading (China) Co., Ltd. published April 21, 2019. Recall level: Level 2 Recall. Ausendo Medical Device Trading (China) Co., Ltd. initiated a voluntary Class II recall of its Creati

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Orsendo Medical Devices Trading (China) Co., Ltd. is voluntarily recalling creatine kinase assay dry strips (rate method).
- Company Name: Orsendo Medical Equipment Trading (China) Co., Ltd.
- Publication Date: 2019-04-21
- Product Name: Creatine kinase assay dry slides (rate method)
- Recall Level: Level 2 Recall
- Recall Reason: When using a fully automated biochemical analyzer, VITROS CK dry tablets do not meet the requirement of a stability time of ≤1 week.
- Discovering Company: Orsendo Medical Equipment Trading (China) Co., Ltd.
- Manufacturing Company: Orsendo Medical Equipment Trading (China) Co., Ltd.
- Summary: Ausendo Medical Device Trading (China) Co., Ltd. initiated a voluntary Class II recall of its Creatine Kinase Assay Dry Tablets (Rate Method), publicly reported by the National Medical Products Administration (NMPA) on April 21, 2019. The company reported the recall event to the Shanghai Food and Drug Administration. The main issue identified was that the VITROS CK dry tablets failed to meet the critical on-machine stability requirement of ≤1 week when used with fully automated biochemical analyzers. This stability non-compliance could potentially affect the accuracy and reliability of diagnostic test results. Under the regulatory framework of the NMPA, the company undertook this voluntary recall action to address the product deficiency. Required actions included the recall of affected product models, specifications, and batches, with detailed information available in a specific Medical Device Recall Event Report Form, ensuring product safety and quality.

Company: https://www.keypedia.com/companies/orsendo-medical-equipment-trading-china-co-ltd/9d283785-b2ea-4291-8250-5927daf06726