# China NMPA Product Recall - Parathyroid hormone assay kit (chemiluminescence method) Intact PTH (iPTH)

Source: https://www.globalkeysolutions.net/records/china_product_recall/beckman-coulter-inc/0ff8b680-3e59-4e5f-805b-d0cfa68a2da2/
Source feed: China

> China NMPA product recall for Parathyroid hormone assay kit (chemiluminescence method) Intact PTH (iPTH) by Beckman Coulter, Inc. published December 23, 2024. Recall level: Level 2 Recall. Beckman Coulter, Inc. has initiated a voluntary Level II recall for its Parathyroid Hormone Assay Ki

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Beckman Coulter, Inc. is voluntarily recalling its Parathyroid Hormone Assay Kit (Chemiluminescence Method).
- Company Name: Beckman Coulter, Inc.
- Publication Date: 2024-12-23
- Product Name: Parathyroid hormone assay kit (chemiluminescence method) Intact PTH (iPTH)
- Recall Level: Level 2 Recall
- Recall Reason: Some batches of products have insufficient reagent volume filling.
- Discovering Company: Beckman Coulter Trading (China) Co., Ltd.
- Manufacturing Company: Beckman Coulter, Inc.
- Summary: Beckman Coulter, Inc. has initiated a voluntary Level II recall for its Parathyroid Hormone Assay Kits (Chemiluminescence Method), specifically impacting certain batches of the Intact PTH (iPTH) Parathyroid Hormone Assay Kits. This action, publicly announced by the National Medical Products Administration (NMPA) on December 23, 2024, stems from a critical quality control issue: insufficient reagent volume filling found in specific production lots. This deficiency could potentially compromise the accuracy and reliability of diagnostic results derived from these assays, posing a risk to patient care. While the document does not mention specific inspection dates, the recall is a voluntary measure undertaken by the manufacturer to address a detected product flaw. Beckman Coulter Trading (China) Co., Ltd. reported this issue to the NMPA, the primary regulatory body responsible for medical devices in China. The affected kits are registered under National Medical Device Registration Certificate No. 20172402183. Importantly, the particular products subject to this recall were not imported into China. Required actions involve the execution of this Level II voluntary recall, with comprehensive details on specifications and batch numbers available in the attached "Medical Device Recall Event Report Form," enabling proper identification and management of the affected products. This proactive recall demonstrates the company's commitment to product quality and patient safety within the regulatory framework established by the NMPA.

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