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

Source: https://www.globalkeysolutions.net/records/china_product_recall/beckman-coulter-inc/31f4add9-e0a9-43cf-ac27-c665013298f3/
Source feed: China

> China NMPA product recall for Vitamin B12 Assay Kit (Chemiluminescence Method) by Beckman Coulter, Inc. published May 02, 2012. Recall level: . Beckman Coulter initiated a voluntary recall of specific batches of its Vitamin B12 Assay Kits (Chem

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Beckman Coulter is recalling its Vitamin B12 Assay Kit (Chemiluminescence Assay).
- Company Name: Beckman Coulter, Inc.
- Publication Date: 2012-05-02
- Product Name: Vitamin B12 Assay Kit (Chemiluminescence Method)
- Recall Reason: When using the Access Vitamin B12 Assay Kit with batch number 170089, 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: Beckman Coulter initiated a voluntary recall of specific batches of its Vitamin B12 Assay Kits (Chemiluminescence Method), identified by batch number 170089 and item number 33000, as reported on April 6, 2012, and published by the National Medical Products Administration (NMPA) on May 2, 2012. The recall was prompted by the potential for these kits to produce erroneous results, either higher or lower than the normal reference range, which could impact patient diagnoses. Operating under the oversight of regulatory bodies like the NMPA (formerly SFDA, as indicated by the registration certificate SFDA(1)20092401983), Beckman Coulter confirmed that this particular recall primarily affects overseas markets, including the USA, Italy, France, and Germany. The company explicitly stated that no affected products were sold or imported into the Chinese market, rendering the local sales quantity as zero. Despite the absence of affected products in China, the NMPA proactively instructed the Food and Drug Administrations across all provinces, autonomous regions, and municipalities to enhance their supervision and management over this product line. This directive ensures continued vigilance and public safety within China, even for products subject to overseas recalls. The required action by Beckman Coulter was the execution of this overseas recall, with no domestic corrective actions needed due to zero sales in China.

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