China NMPA Product Recall - Blood glucose test strips

Sinocare Biosensor Co., Ltd. (also known as Sannuo Biosensor Co., Ltd.) initiated a voluntary Class III recall of its An model Blood Glucose Test Strips (batch number 131007, calibration code C39) as reported by the National Medical Products Administration (NMPA) on December 14, 2021. The recall, formally reported by the company on December 7, 2021, stems from a critical error in the product's calibration code. This defect poses a significant risk of generating excessively high blood glucose test values, which could lead to misinterpretation of a patient's blood glucose levels and potentially impact treatment decisions for individuals monitoring their condition. The affected products, specifically 13,630 boxes manufactured and 13,420 boxes sold in China, are intended for monitoring glucose in fresh capillary whole blood. In response, Sinocare Biosensor Co., Ltd. outlined several required actions. These include immediate inventory checks to isolate and halt sales of the identified batch, contacting all relevant distributors to cease sales and retrieve affected units, and reaching out to individual e-commerce users via phone and SMS to advise them to stop use and return the strips for replacement, with the company covering all postage costs. This comprehensive approach aims to mitigate potential health risks associated with the erroneous test results.