China NMPA Product Recall - Freelite Human Lambda Free Kit (Immunoturbidimetric Assay)

Bidetsai (Shanghai) Trading Co., Ltd. initiated a voluntary Class III recall of its Freelite® Human Lambda Free Kit (Immunoturbidimetric Assay) on February 23, 2021, as reported by the Shanghai Municipal Drug Administration. The recall was prompted by customer feedback revealing an error in the Chinese instructions for use. Specifically, the "Test Methods" section incorrectly stated the sample/diluted sample volume as 15µl, when the correct volume is 5µl. This discrepancy could lead to increased reactivity in the calibration curve. While quality control (QC) results might still appear within acceptable limits, this issue could result in customers using the diagnostic reagent in an unverified operational mode. As a required action, the company advised that if, after adjusting to the correct 5µl parameter, the QC results align with the product label's specified range, the affected kits can continue to be used and patient results reported. This measure ensures patient safety and accurate diagnostic outcomes under the NMPA's regulatory oversight.