# China NMPA Product Recall - Vitamin B12 Assay Kit (Chemiluminescence Method)

Source: https://www.globalkeysolutions.net/records/china_product_recall/beckman-coulter-inc/914cdb46-a827-4b79-9204-4e174edc1c99/
Source feed: China

> China NMPA product recall for Vitamin B12 Assay Kit (Chemiluminescence Method) by Beckman Coulter, Inc. published April 19, 2013. Recall level: . The National Medical Products Administration (NMPA) published a notice on April 19, 2013, regarding 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Beckman Coulter is recalling its Vitamin B12 assay kit (chemiluminescence method).
- Company Name: Beckman Coulter, Inc.
- Publication Date: 2013-04-19
- Product Name: Vitamin B12 Assay Kit (Chemiluminescence Method)
- Recall Reason: When using the Access Vitamin B12 Assay Kit with batch number 270139, erroneous results may occur, either higher or lower than the normal reference range.
- Discovering Company: Beckman Coulter Trading (China) Co., Ltd.
- Manufacturing Company: Beckman Coulter, Inc.
- Summary: The National Medical Products Administration (NMPA) published a notice on April 19, 2013, regarding a voluntary product recall initiated by Beckman Coulter. The recall, reported on March 29, 2013, concerns specific batches of Beckman Coulter's Vitamin B12 Assay Kits (Chemiluminescence Method), registered under CFDA (Imported) 2009 No. 2401983. The primary issue prompting the recall is that kits from batch number 270139 may yield inaccurate results, presenting values either higher or lower than the established normal reference range. This could potentially affect the accurate quantitative determination of vitamin B12 levels in human serum and plasma. Beckman Coulter Trading (China) Co., Ltd. clarified that this specific recall is an overseas action, primarily impacting regions such as Italy, France, and Germany. The company confirmed that no affected products from the identified batch were imported into or sold within the Chinese market. Therefore, no direct consumer action is required within China. The NMPA, operating under its regulatory framework, instructed provincial, autonomous region, and municipality food and drug administrations to enhance their supervision and management over similar products to ensure public safety and product quality. This proactive measure aims to prevent potential issues with comparable medical devices in the Chinese market.

Company: https://www.globalkeysolutions.net/companies/beckman-coulter-inc/7d99d114-1669-40c5-965a-4ba74c77a825/