China NMPA Product Recall - Triple quadrupole mass spectrometer

Shanghai Aibocais Analytical Instruments Trading Co., Ltd. initiated a voluntary Class II recall for its Triple Quadrupole Mass Spectrometer, model API 3200MD, equipped with Analyst MD software versions 1.6.1/1.6.2. The recall, reported to the National Medical Products Administration (NMPA) framework, commenced on February 29, 2016. The core issue involves a software defect in the "result list self-compiled formula function," which can produce incorrect calculations if individual samples are deleted rather than processed in batches. These instruments, manufactured by AB Sciex Pte. Ltd., are crucial for qualitative and quantitative analysis of various compounds in human samples, including drug components. Although the potential for erroneous results exists, the company deems the probability of health hazards extremely low, citing the infrequent use of the specific operation and an absence of related complaints in China. Immediate required actions include advising users to employ a workaround by deleting samples, saving, closing, and reopening the page before outputting results. Furthermore, the manufacturer is developing a permanent software repair plan, anticipated to be completed within four weeks, to fully resolve the defect impacting the 51 units imported and sold in China.