China NMPA Product Recall - Uric acid test strips (dry chemistry method)

Roche Diagnostics Products (Shanghai) Co., Ltd., working with its manufacturer Roche Diagnostics GmbH, initiated a voluntary Class III recall for its Uric Acid Test Strips (Dry Chemistry Method) on August 3, 2015. An internal investigation conducted by Roche identified a critical issue: the test strips might yield erroneously low uric acid results when analyzing whole blood samples where the hematocrit value exceeds 48%. This recall specifically impacts product item number 10745103202, with 373 boxes sold in China and 415 globally. Despite receiving no global complaints related to this issue, the company, operating under the National Medical Products Administration (NMPA) framework, proactively undertook this action to safeguard user and patient safety. Corrective measures include updating the product packaging to prominently feature a warning regarding the revised 48% upper limit for hematocrit in whole blood samples. Additionally, Roche Diagnostics issued notification letters to all affected customers, providing comprehensive details of the incident and the necessary actions to be taken, demonstrating a commitment to product integrity and user safety.