# China NMPA Product Recall - Carbohydrate Antigen 19-9 Assay Kit (Chemiluminescent Microparticle Immunoassay)

Source: https://www.globalkeysolutions.net/records/china_product_recall/abbott-laboratories/aa5359bb-e2ec-42fe-8c3f-ef863ee2808c/
Source feed: China

> China NMPA product recall for Carbohydrate Antigen 19-9 Assay Kit (Chemiluminescent Microparticle Immunoassay) by Abbott Laboratories published June 20, 2012. Recall level: . The National Medical Products Administration (NMPA) issued an alert concerning a voluntary recall in

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Abbott Laboratories is recalling its Carbohydrate Antigen 19-9 Assay Kit (Chemiluminescent Microparticle Immunoassay).
- Company Name: Abbott Laboratories
- Publication Date: 2012-06-20
- Product Name: Carbohydrate Antigen 19-9 Assay Kit (Chemiluminescent Microparticle Immunoassay)
- Recall Reason: Abbott has confirmed that this batch of ARCHITECT CA 19-9XR reagents can cause patients' test results to drift upwards.
- Discovering Company: Abbott Trading (Shanghai) Co., Ltd.
- Manufacturing Company: Abbott Laboratories
- Summary: The National Medical Products Administration (NMPA) issued an alert concerning a voluntary recall initiated by Abbott Laboratories for its Carbohydrate Antigen 19-9 Assay Kit (Chemiluminescent Microparticle Immunoassay). Reported by Abbott Trading (Shanghai) Co., Ltd. on June 4, 2012, and subsequently publicized by the NMPA on June 20, 2012, the recall addresses a specific batch (08851M500) of the ARCHITECT CA 19-9XR reagents. The primary issue identified was that this particular batch consistently led to an upward drift in patient test results, raising concerns about diagnostic accuracy. As a required action, Abbott Laboratories confirmed the defect in this batch and promptly instructed customers globally, including those in China, to cease using the affected kits immediately. The company committed to the destruction of all recalled products. In response, the NMPA mandated that food and drug administrations across all provinces, autonomous regions, and municipalities enhance their supervision and management of similar medical devices to ensure product reliability and protect public health. This recall underscores the manufacturer's obligation under regulatory frameworks to rectify product performance deficiencies affecting diagnostic integrity.

Company: https://www.globalkeysolutions.net/companies/abbott-laboratories/1b90ea06-9339-4fec-845b-7b265e8fee86/