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

Source: https://www.globalkeysolutions.net/records/china_product_recall/beckman-coulter-inc/b4936582-685a-486a-84f8-51b1e26b81c6/
Source feed: China

> China NMPA product recall for Vitamin B12 Assay Kit (Chemiluminescence Method) by Beckman Coulter, Inc. published March 27, 2025. Recall level: Level 2 Recall. Beckman Coulter, Inc. is conducting a voluntary Class II recall of its Vitamin B12 Assay Kit (Chemil

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Beckman Coulter, Inc. is voluntarily recalling its Vitamin B12 Assay Kit (Chemiluminescence Assay).
- Company Name: Beckman Coulter, Inc.
- Publication Date: 2025-03-27
- Product Name: Vitamin B12 Assay Kit (Chemiluminescence Method)
- Recall Level: Level 2 Recall
- Recall Reason: Product defective
- Discovering Company: Beckman Coulter Trading (China) Co., Ltd.
- Manufacturing Company: Beckman Coulter, Inc.
- Summary: Beckman Coulter, Inc. is conducting a voluntary Class II recall of its Vitamin B12 Assay Kit (Chemiluminescence Method), specifically the Access Vitamin B12 kit (National Medical Device Registration Certificate 20172400054). This action, reported by Beckman Coulter Trading (China) Co., Ltd., was announced by the National Medical Products Administration (NMPA) on March 27, 2025. The recall is initiated due to identified product non-compliance. While the document doesn't specify inspection dates, the recall itself serves as a regulatory action point. The main issue revolves around the product's failure to meet established compliance standards, indicating a quality or performance deviation. Under the regulatory framework of the NMPA, the manufacturer is required to undertake this voluntary recall to address the identified deficiency. A crucial aspect of this recall is that the specific batches and models of the affected Vitamin B12 Assay Kit were not imported into the Chinese market, limiting its direct impact within China. Further details on the affected products are documented in the "Medical Device Recall Event Report Form" provided by Beckman Coulter Trading (China) Co., Ltd.

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