China NMPA Product Recall - Ammonia Assay Kit (Glutamate Dehydrogenase Method)

Abbott Trading (Shanghai) Co., Ltd., in coordination with the National Medical Products Administration (NMPA), initiated a voluntary Level III recall of its Ammonia Assay Kit (Glutamate Dehydrogenase Method) on September 28, 2015. The recall, also involving manufacturer Sentinel CH SpA, was prompted by a critical manufacturing defect affecting product batch 42072L101. This defect caused the affected kits to report values below the lower linear limit when testing heparin plasma samples, rendering accurate patient results unobtainable and leading to significant delays in test outcomes. The scope of this issue was global, though only two boxes of the affected products were sold/imported into China. To address this serious concern, Abbott Trading (Shanghai) Co., Ltd. has taken immediate corrective actions. Customers were promptly notified to cease using the compromised product. All recalled kits are slated for destruction to prevent any further use and potential misdiagnosis. This proactive measure underscores the company's commitment to product quality and patient safety under the regulatory oversight of the NMPA.