China NMPA Product Recall - Microalbumin Assay Kit (Immunoturbidimetric Method)

This National Medical Products Administration (NMPA) recall report, dated September 30, 2010, details an action taken by Ortho-Clinical Diagnostics, Inc. (USA), distributed by Johnson & Johnson (Shanghai) Medical Devices Co., Ltd., regarding its Microalbumin Assay Kit. The core issue was that the kit could produce falsely low microalbumin detection results. Specifically, undiluted urine samples with true microalbumin levels between 300 and 800 mg/dL might exhibit a negative bias, incorrectly reporting values within the original 0.6-19.0 mg/dL reportable range. Despite this significant inaccuracy, the company reported no customer complaints or adverse events related to the problem.

Operating under the NMPA regulatory framework, Johnson & Johnson initiated several corrective actions. This involved communicating with global customers and obtaining confirmation of awareness. A key action was the temporary reduction of the product's upper reportable range from 19.0 mg/dL to 7.0 mg/dL. Customers were required to update their calibration data disks for existing Generation 2, 3, and 4 kits to ensure accuracy within this revised range. Johnson & Johnson committed to identifying the root cause of the bias and anticipated reverting to the original range with Generation 5 products. Trained technical staff and distributors were available to support customers with questions and disk upgrades. The recall implementation was projected for completion by August 31st.