China NMPA Product Recall - Carbohydrate Antigen 19-9 Detection Kit (Enzyme-Linked Immunofluorescence Assay)

The National Medical Products Administration (NMPA) issued an announcement on October 11, 2017, regarding a voluntary Class III recall initiated by bioMérieux Diagnostics (Shanghai) Co., Ltd. The recall pertained to a specific batch of their Carbohydrate Antigen 19-9 Detection Kit (Enzyme-Linked Immunofluorescence Assay), registered under CFDA (Imported) 2014 No. 3401095. The primary issue identified was that the affected product batch had been subjected to low temperatures during transportation, raising concerns about its overall quality and performance integrity. In response to this potential quality compromise and under the NMPA's regulatory guidance, bioMérieux Diagnostics (Shanghai) Co., Ltd. took prompt action by voluntarily recalling one kit of the identified product. This measure aims to address and mitigate any risks associated with the temperature-exposed kits. Further comprehensive details, including specific model numbers, specifications, and batch information of the recalled product, are available in the "Medical Device Recall List" attachment provided by the NMPA.