# China NMPA Product Recall - Unbound estriol assay kit (chemiluminescence method)

Source: https://www.globalkeysolutions.net/records/china_product_recall/beckman-coulter-trading-china-co-ltd/e660eb2f-b74f-4b7d-bee6-042a6aff0689/
Source feed: China

> China NMPA product recall for Unbound estriol assay kit (chemiluminescence method) by Beckman Coulter Trading (China) Co., Ltd. published September 08, 2020. Recall level: Level 2. Beckman Coulter Trading (China) Co., Ltd. initiated a voluntary Class II recall of its Unbound Estri

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Beckman Coulter Trading (China) Co., Ltd. is voluntarily recalling its Unbound Estriol Assay Kit (Chemiluminescence Method).
- Company Name: Beckman Coulter Trading (China) Co., Ltd.
- Publication Date: 2020-09-08
- Product Name: Unbound estriol assay kit (chemiluminescence method)
- Recall Level: Level 2
- Recall Reason: When the product in question was tested using batches of unbound estriol reagent listed in the recall report, slightly elevated bovine alkaline phosphatase-related interference (BOP) may have been observed in patient samples. An internal survey of 300 samples confirmed that approximately 3% of patient samples may have exhibited BOP-related interference.
- Discovering Company: Beckman Coulter Trading (China) Co., Ltd.
- Manufacturing Company: Beckman Coulter Trading (China) Co., Ltd.
- Summary: Beckman Coulter Trading (China) Co., Ltd. initiated a voluntary Class II recall of its Unbound Estriol Assay Kit (Chemiluminescence Method) on September 8, 2020. This action, reported through the National Medical Products Administration (NMPA) and Shanghai Municipal Drug Administration, was prompted by an internal investigation revealing potential issues with specific reagent batches. The company identified that approximately 3% of patient samples could exhibit slightly elevated interference related to bovine alkaline phosphatase when using the affected kits. This interference posed a risk to the accuracy of test results. While no specific inspection dates were provided, the company’s proactive reporting highlights its compliance with regulatory expectations regarding product safety and quality. The required action involves the recall of the specified medical device batches, with detailed information available in the "Medical Device Recall Event Report Form" referenced by the NMPA. This ensures the removal of potentially unreliable products from circulation to safeguard patient diagnostic accuracy.

Company: https://www.globalkeysolutions.net/companies/beckman-coulter-trading-china-co-ltd/ba5d4d83-dfa7-4af5-bc20-f9174025eaad/