# China NMPA Product Recall - Cholesterol (CHOL) Reagent Kit (Colorimetric Method)

Source: https://www.globalkeysolutions.net/records/china_product_recall/beckman-coulter-inc/036f30f2-1878-414b-94d2-ca94415e01c4
Source feed: China

> China NMPA product recall for Cholesterol (CHOL) Reagent Kit (Colorimetric Method) by Beckman Coulter, Inc. published December 02, 2021. Recall level: Level 3 Recall. Beckman Coulter, Inc., through its China subsidiary, initiated a voluntary Class III recall of its C

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Beckman Coulter, Inc. is voluntarily recalling its Cholesterol (CHOL) Reagent test kit (colorimetric method).
- Company Name: Beckman Coulter, Inc.
- Publication Date: 2021-12-02
- Product Name: Cholesterol (CHOL) Reagent Kit (Colorimetric Method)
- Recall Level: Level 3 Recall
- Recall Reason: This issue involves specific product models and batches exhibiting errors such as exceeding the low-level calibration range (low OCR level) and/or Back to Back (B/B), resulting in reagent failure in the accuracy-tested kit (colorimetric method).
- Discovering Company: Beckman Coulter (China) Co., Ltd.
- Manufacturing Company: Beckman Coulter, Inc.
- Summary: Beckman Coulter, Inc., through its China subsidiary, initiated a voluntary Class III recall of its Cholesterol (CHOL) Reagent Test Kit (Colorimetric Method), reported on December 2, 2021, to the National Medical Products Administration (NMPA). The recall was prompted by significant product reliability issues observed in specific models and batches of the kits. These issues included instances where the reagent exceeded the low calibration range (low OCR level) and/or displayed Back to Back (B/B) errors. Such deviations compromised the accuracy and dependability of the test kits, rendering them unreliable for diagnostic use. The company's action, a voluntary recall of the affected products (Registration Certificate No.: 20182402320), demonstrates adherence to regulatory responsibilities under NMPA oversight. While specific inspection dates are not detailed, the recall announcement itself signifies a regulatory response. This measure ensures that medical devices meet established quality and performance standards, safeguarding patient health and maintaining confidence in diagnostic tools by addressing quality concerns proactively.

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