# China NMPA Product Recall - B-type cerebral natriuretic peptide calibrator

Source: https://www.globalkeysolutions.net/records/china_product_recall/abbott-trading-shanghai-co-ltd/130b22e5-d1a3-4cb9-a633-9f39eeae36a0/
Source feed: China

> China NMPA product recall for B-type cerebral natriuretic peptide calibrator by Abbott Trading (Shanghai) Co., Ltd. published June 11, 2019. Recall level: Level 3 Recall. Abbott Trading (Shanghai) Co., Ltd. initiated a voluntary Class III recall of its B-type Natriuretic

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Abbott Trading (Shanghai) Co., Ltd. is voluntarily recalling its B-type brain natriuretic peptide calibrators.
- Company Name: Abbott Trading (Shanghai) Co., Ltd.
- Publication Date: 2019-06-11
- Product Name: B-type cerebral natriuretic peptide calibrator
- Recall Level: Level 3 Recall
- Recall Reason: The products in question were found by Abbott to have potential issues over time with the calibrators from the aforementioned batches, including drift in patient results and quality control results for the B-type natriuretic peptide (BNP) test.
- Discovering Company: Abbott Trading (Shanghai) Co., Ltd.
- Manufacturing Company: Abbott Trading (Shanghai) Co., Ltd.
- Summary: Abbott Trading (Shanghai) Co., Ltd. initiated a voluntary Class III recall of its B-type Natriuretic Peptide (BNP) Calibrator, as reported by the National Medical Products Administration (NMPA) on June 11, 2019. The Shanghai Food and Drug Administration Medical Device Registration Certificate No.: 2019-132 is associated with this product. The recall was prompted by concerns that specific batches of the calibrators might lead to drift in both patient and quality control results for the BNP test over time. This potential drift could impact the accuracy of diagnostic measurements. Abbott Trading (Shanghai) Co., Ltd. is responsible for reporting this issue. The recall action requires the company to address the affected products, with detailed information on models, specifications, and batches available in the "Medical Device Recall Event Report Form." This voluntary action underscores the company's commitment to product safety and regulatory compliance under the oversight of the NMPA.

Company: https://www.globalkeysolutions.net/companies/abbott-trading-shanghai-co-ltd/851d8fbf-2dac-497e-bf33-820114081013/