China NMPA Product Recall - Growth hormone assay kit (chemiluminescence method)

Siemens Medical Diagnostics Products (Shanghai) Co., Ltd. initiated a Class III voluntary recall for its Growth Hormone Assay Kit (Chemiluminescence Method) due to a printing error on the Chinese label. The issue, reported on October 28, 2015, and published by the National Medical Products Administration (NMPA) on December 8, 2015, involved the incorrect (older) medical device registration certificate number and product standard number being printed. The affected products, specifically model L2KGRH2 (200 tests/box) with batch numbers 158 and 159, were designed for in vitro quantitative detection of human serum growth hormone. In response, Siemens Medical Diagnostics Products (Shanghai) Co., Ltd. was required to immediately notify all affected customers via a customer letter, instruct them to cease using the product, and recall all unused inventory. The recall impacted 181 units sold in China out of 342 produced or imported.