China NMPA Product Recall - Uric acid assay kit (uricase-peroxidase method), total cholesterol assay kit (enzymatic method), triglyceride assay kit (GPO-POD method), lactic acid assay kit (enzymatic method), lipase assay kit (chromogen substrate method), creatinine assay kit (sarcosine oxidase method)

Beckman Coulter Trading (China) Co., Ltd. initiated a voluntary Level III recall, publicized by the National Medical Products Administration (NMPA) on July 6, 2016, following a report on May 23, 2016. The recall involves several in-vitro diagnostic assay kits manufactured by Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd., Beckman Coulter, Inc., and Beckman Coulter Ireland Inc.

The core issue is a potential drug interference where affected kits—including Uric Acid, Total Cholesterol, Triglyceride, Lactate, Lipase, and Creatinine Assay Kits—may produce falsely low results in patients taking metamizole sodium (Analgin). This interference carries a risk of inaccurate clinical assessments.

As a required action, Beckman Coulter is revising the instruction manuals for these assays. A new statement will be added to the interfering substances section, cautioning that drawing blood immediately after or during metamizole treatment may lead to erroneously low results. It advises that for critical analytical items, blood should be collected prior to metamizole administration. All affected customers will be notified of these important updates to ensure proper use and accurate diagnostic outcomes.