# China NMPA Product Recall - Creatine kinase isoenzyme MB assay (dry slide, rate method)

Source: https://www.globalkeysolutions.net/records/china_product_recall/orsendo-medical-equipment-trading-china-co-ltd/0c9c67b9-91d9-430f-aade-99b69bf8c0c6/
Source feed: China

> China NMPA product recall for Creatine kinase isoenzyme MB assay (dry slide, rate method) by Orsendo Medical Equipment Trading (China) Co., Ltd. published January 06, 2021. Recall level: Level 2 Recall. Aussendo Medical Devices Trading (China) Co., Ltd. initiated a voluntary Class II recall for its Cre

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Orsendo Medical Devices Trading (China) Co., Ltd. is voluntarily recalling its creatine kinase isoenzyme MB assay dry strips (rate method).
- Company Name: Orsendo Medical Equipment Trading (China) Co., Ltd.
- Publication Date: 2021-01-06
- Product Name: Creatine kinase isoenzyme MB assay (dry slide, rate method)
- Recall Level: Level 2 Recall
- Recall Reason: The coating of the creatine kinase isoenzyme MB assay dry slide (rate method) cannot adequately inhibit CK-MM when total CK > 1000 U/L. Samples with total CK < 1000 U/L may show falsely elevated CKMB results.
- Discovering Company: Orsendo Medical Equipment Trading (China) Co., Ltd.
- Manufacturing Company: Orsendo Medical Equipment Trading (China) Co., Ltd.
- Summary: Aussendo Medical Devices Trading (China) Co., Ltd. initiated a voluntary Class II recall for its Creatine Kinase Isoenzyme MB Assay Dry Tablets (Rate Method), announced by the National Medical Products Administration (NMPA) on January 6, 2021. The recall stems from a significant performance issue where the diagnostic strips can produce falsely elevated Creatine Kinase-MB (CK-MB) results. The product's instructions indicated a limitation where total CK activity exceeding 1000 U/L might lead to elevated CK-MB, suggesting dilution for such samples. However, subsequent findings revealed that the strips' coating inadequately inhibits CK-MM when total CK is above 1000 U/L. More critically, samples with total CK *below* 1000 U/L may also exhibit these inaccurate, falsely high CK-MB readings, indicating a broader unreliability than initially documented. This defect poses a risk of misdiagnosis or inappropriate patient management due to erroneous cardiac biomarker results. Ausendo is undertaking this recall to address the product's inability to reliably provide accurate measurements. Specific affected product models, specifications, and batch numbers are detailed in the accompanying Medical Device Recall Event Report Form.

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