# China NMPA Product Recall - Folic acid assay kit (direct chemiluminescence method) Folate (FOL)

Source: https://www.globalkeysolutions.net/records/china_product_recall/siemens-healthcare-diagnostics-inc/9646364e-3ec3-4cd5-8c57-f30fd12de8b0
Source feed: China

> China NMPA product recall for Folic acid assay kit (direct chemiluminescence method) Folate (FOL) by Siemens Healthcare Diagnostics Inc. published December 08, 2020. Recall level: Level 3 Recall. Siemens Medical Diagnostics Products (Shanghai) Co., Ltd. has initiated a Class III voluntary recall

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Siemens Medical Diagnostics Products (Shanghai) Co., Ltd. is voluntarily recalling its Folic Acid Assay Kit (Direct Chemiluminescence Method) containing Folate (FOL).
- Company Name: Siemens Healthcare Diagnostics Inc.
- Publication Date: 2020-12-08
- Product Name: Folic acid assay kit (direct chemiluminescence method) Folate (FOL)
- Recall Level: Level 3 Recall
- Recall Reason: On the ADVIA Centaur XP and ADVIA Centaur XPT platforms, homocysteine may intermittently interfere with folic acid detection and lead to elevated results.
- Discovering Company: Siemens Medical Diagnostics Products (Shanghai) Co., Ltd.
- Manufacturing Company: Siemens Healthcare Diagnostics Inc.
- Summary: Siemens Medical Diagnostics Products (Shanghai) Co., Ltd. has initiated a Class III voluntary recall of its Folic Acid Assay Kit (Direct Chemiluminescence Method) Folate (FOL). This action, publicly documented in a December 8, 2020, report from the Shanghai Municipal Drug Administration, updates a previously identified concern from 2019. The fundamental issue centers on an intermittent interference caused by homocysteine during folic acid detection performed on the ADVIA Centaur XP and ADVIA Centaur XPT diagnostic platforms. This interference has the potential to yield inaccurately elevated folic acid results, which could impact patient diagnoses and treatment decisions. Operating under the regulatory framework of the National Medical Products Administration (NMPA) and the Shanghai Municipal Drug Administration, Siemens Healthcare Diagnostics Inc. has developed and released a new mitigation and cleaning procedure specifically designed to address and correct this problem. The voluntary recall encompasses specific models, specifications, and batches of the affected assay kit, with comprehensive details provided in the "Medical Device Recall Event Report Form." This measure highlights the company's commitment to product integrity and ensuring the reliability of diagnostic testing for folic acid.

Company: https://www.globalkeysolutions.net/companies/siemens-healthcare-diagnostics-inc/4ca41d2b-8be7-40e5-b7e5-d9e3afdc8bce