# China NMPA Product Recall - Uric acid assay kit (enzyme-catalyzed colorimetric method); Creatinine assay kit (sarcosine oxidase method); Lactate assay kit (enzymatic method); Lipase assay kit (chromogen substrate method); Cholesterol assay kit (enzymatic method)

Source: https://www.globalkeysolutions.net/records/china_product_recall/beckman-coulter-inc/173f96df-46bb-42c8-b00a-01ed8052675f/
Source feed: China

> China NMPA product recall for Uric acid assay kit (enzyme-catalyzed colorimetric method); Creatinine assay kit (sarcosine oxidase method); Lactate assay kit (enzymatic method); Lipase assay kit (chromogen substrate method); Cholesterol assay kit (enzymatic method) by Beckman Coulter, Inc. published February 15, 2015. Recall level: Level II. Beckman Coulter Trading (China) Co., Ltd. initiated a Class II voluntary recall on February 15, 2015

---

## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Beckman Coulter Trading (China) Co., Ltd. is voluntarily recalling its uric acid test kits, creatinine test kits, lactate test kits, lipase test kits, and cholesterol test kits.
- Company Name: Beckman Coulter, Inc.
- Publication Date: 2015-02-15
- Product Name: Uric acid assay kit (enzyme-catalyzed colorimetric method); Creatinine assay kit (sarcosine oxidase method); Lactate assay kit (enzymatic method); Lipase assay kit (chromogen substrate method); Cholesterol assay kit (enzymatic method)
- Recall Level: Level II
- Recall Reason: N-acetylcysteine (NAC) can interfere with the detection of uric acid, creatinine, lactate, lipase, and cholesterol in assay kits, potentially leading to lower results. NAC is an antioxidant that can interfere with experiments using Trinder chemistry reactions; the degree of interference depends on the analyte.
- Discovering Company: Beckman Coulter Trading (China) Co., Ltd.
- Manufacturing Company: Beckman Coulter, Inc.
- Summary: Beckman Coulter Trading (China) Co., Ltd. initiated a Class II voluntary recall on February 15, 2015, for several diagnostic test kits. The affected products include test kits for uric acid, creatinine, lactate, lipase, and cholesterol. This action was taken after the company identified N-acetylcysteine (NAC) as an interfering substance. NAC interference can lead to inaccurately low results for these critical diagnostic parameters, particularly in patients undergoing treatment for acetaminophen overdose, where NAC is administered. The National Medical Products Administration (NMPA) oversees this recall. Beckman Coulter reported that NAC, an antioxidant, can interfere with specific enzymatic assays that utilize Trinder chemistry, which relies on hydrogen peroxide generation. The degree of interference is analyte-dependent. As part of the corrective actions, Beckman Coulter is updating the instruction manuals for the affected test kits. New statements will be added to the "Interferences" section, warning users that in patients treated with NAC, erroneous low results may occur for enzymatic creatinine, cholesterol, uric acid, lactate, and lipase tests. These updated warnings are effective immediately and remain valid until the full instructions for use are revised. Notably, the company determined that no intervention or retrospective review of previously obtained results is required.

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