# China NMPA Product Recall - Blood gas analysis test card (dry electrochemical method)

Source: https://www.globalkeysolutions.net/records/china_product_recall/epocal-inc-canada/9cb62fea-4819-4993-8b2d-cffe58a940c0/
Source feed: China

> China NMPA product recall for Blood gas analysis test card (dry electrochemical method) by Epocal Inc. (Canada) published September 04, 2020. Recall level: Level 3 Recall. Epocal Inc. (Canada) has initiated a voluntary Class III recall of its Blood Gas Analysis Test Cards

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Epocal Inc. (Canada) is voluntarily recalling its blood gas analysis test cards (dry electrochemical method).
- Company Name: Epocal Inc. (Canada)
- Publication Date: 2020-09-04
- Product Name: Blood gas analysis test card (dry electrochemical method)
- Recall Level: Level 3 Recall
- Recall Reason: This involves occasional (low-biased) discrepancies in blood glucose results related to specific product models and batches.
- Discovering Company: Siemens Medical Diagnostics Products (Shanghai) Co., Ltd.
- Manufacturing Company: Epocal Inc. (Canada)
- Summary: Epocal Inc. (Canada) has initiated a voluntary Class III recall of its Blood Gas Analysis Test Cards (Dry Electrochemical Method). This action, reported by Siemens Medical Diagnostics Products (Shanghai) Co., Ltd. and published by the National Medical Products Administration (NMPA) on September 4, 2020, addresses occasional inconsistencies found in blood glucose results. Specifically, affected test cards exhibited a low bias, potentially leading to inaccurate readings for patients. The recall pertains to particular models and batches of the product, which holds registration certificate number 20182400183 in China. This voluntary recall demonstrates the company's commitment to product safety and compliance with regulatory standards set by the NMPA. Further details regarding the specific affected products are available in the "Medical Device Recall Table" and the attached "Medical Device Recall Event Report Form" provided by Epocal Inc. (Canada).

Company: https://www.globalkeysolutions.net/companies/epocal-inc-canada/5fce3257-cb0b-4fe3-b38b-2d038658cd74/