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

Source: https://www.globalkeysolutions.net/records/china_product_recall/beckman-coulter-experimental-systems-suzhou-co-ltd/6d2b0912-fcfa-49f0-b8d0-518b01a02c89/
Source feed: China

> China NMPA product recall for Estradiol Assay Kit (Chemiluminescence Method) by Beckman Coulter Experimental Systems (Suzhou) Co., Ltd. published May 06, 2021. Recall level: Level 3 Recall. Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. initiated a voluntary Level Three recall for i

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. is voluntarily recalling its estradiol detection kit (chemiluminescence method).
- Company Name: Beckman Coulter Experimental Systems (Suzhou) Co., Ltd.
- Publication Date: 2021-05-06
- Product Name: Estradiol Assay Kit (Chemiluminescence Method)
- Recall Level: Level 3 Recall
- Recall Reason: Estradiol supplements may significantly increase the concentration of estrone and estrone-3-sulfate in samples if the drug is not completely metabolized. When estrone and estrone-3-sulfate concentrations are measured using an estradiol assay kit (chemiluminescence method), bidirectional interference may occur.
- Discovering Company: Beckman Coulter Experimental Systems (Suzhou) Co., Ltd.
- Manufacturing Company: Beckman Coulter Experimental Systems (Suzhou) Co., Ltd.
- Summary: Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. initiated a voluntary Level Three recall for its Estradiol Assay Kit (Chemiluminescence Method) on May 6, 2021, under the National Medical Products Administration (NMPA) framework. The company internally discovered that when estradiol supplements are not fully metabolized, they can significantly increase concentrations of estrone and estrone-3-sulfate in samples. This elevation leads to bidirectional interference with the assay kit, potentially causing inaccurate results, particularly in samples from patients undergoing endometrial preparation before embryo transfer. 

Furthermore, Beckman Coulter identified a discrepancy between the stated upper limit of reportable results and the S5 calibrator concentration, which could complicate result interpretation. As part of its corrective actions, the company issued a recall notice to its distributors and affected customers. It mandated that test results exceeding the S5 calibrator value should be clearly reported as such. The company also advised against using the estradiol assay as the sole method for routine monitoring of estradiol supplementation effectiveness, emphasizing the importance of comprehensive interpretation alongside other clinical data, such as imaging results. No physical recall of existing products is required, but unsold batches of the affected reagents must be isolated. Future productions of the reagents will incorporate new "Customer Service Guidelines," and the product's Instructions for Use will be officially amended and re-registered to reflect these changes.

Company: https://www.globalkeysolutions.net/companies/beckman-coulter-experimental-systems-suzhou-co-ltd/b1bdab62-43a3-4af1-902c-04b2a6e0e660/