China NMPA Product Recall - Fully automated sample processing system

Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. initiated a voluntary recall, reported to the National Medical Products Administration (NMPA) on April 23, 2015, concerning a Fully Automated Sample Processing System, model TCAutomation. Manufactured by Ortho-Clinical Diagnostics, Inc., the recall addresses a critical software defect affecting versions v3.2.2 and earlier, and v5.0. The primary issues include the system's failure to correctly route urine samples requiring acidification for specific tests (calcium, magnesium, phosphorus) to a "Manual Priority Processing" exit for necessary pretreatment. Additionally, the software permits the creation of "invalid test combinations," where urine samples with conflicting pretreatment requirements (e.g., acidification and alkalization) are processed incorrectly, leading to samples being directed to an "invalid priority processing" exit. Operating under the NMPA's regulatory framework for imported medical devices (Permit No. 20131404786), Johnson & Johnson reported that only one unit of the affected system was imported into China. This single unit was exclusively used for internal training purposes at Johnson & Johnson Academic Centers and was never sold or distributed into the commercial market. Consequently, beyond the initial report to the NMPA, the company stated no further recall actions, investigation, evaluation reports, or implementation plans would be undertaken in China, given the product's contained use and absence from public circulation.