# China NMPA Product Recall - Chronic lymphocytic leukemia chromosome and gene abnormality detection kit (in situ hybridization method)

Source: https://www.globalkeysolutions.net/records/china_product_recall/abbott-trading-shanghai-co-ltd/d22fe75b-b6d5-44df-8f0a-3c8e14e472c3/
Source feed: China

> China NMPA product recall for Chronic lymphocytic leukemia chromosome and gene abnormality detection kit (in situ hybridization method) by Abbott Trading (Shanghai) Co., Ltd. published August 12, 2021. Recall level: Level 2 Recall. Abbott Trading (Shanghai) Co., Ltd. announced a voluntary Class II recall of its Chronic Lymphoblast

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Abbott Trading (Shanghai) Co., Ltd. is voluntarily recalling its Chronic Lymphocytic Leukemia Chromosomal and Genetic Abnormality Detection Kit (In Situ Hybridization Method).
- Company Name: Abbott Trading (Shanghai) Co., Ltd.
- Publication Date: 2021-08-12
- Product Name: Chronic lymphocytic leukemia chromosome and gene abnormality detection kit (in situ hybridization method)
- Recall Level: Level 2 Recall
- Recall Reason: Nine reports have been received globally showing that the Chronic Lymphoblastic Leukemia Chromosomal and Genetic Abnormality Detection Kit (In Situ Hybridization) could not detect the deletion of 13q in samples from known positive patients.
- Discovering Company: Abbott Trading (Shanghai) Co., Ltd.
- Manufacturing Company: Abbott Trading (Shanghai) Co., Ltd.
- Summary: Abbott Trading (Shanghai) Co., Ltd. announced a voluntary Class II recall of its Chronic Lymphoblastic Leukemia Chromosomal and Genetic Abnormality Detection Kit (In Situ Hybridization) on August 12, 2021. This action, reported through the National Medical Products Administration (NMPA) in China, addresses a significant performance deficiency in the diagnostic product. The primary issue identified is the kit's inability to accurately detect the deletion of 13q in samples from patients already confirmed to have this specific genetic abnormality. This functional defect carries serious implications for patient diagnosis and management of chronic lymphoblastic leukemia. The company reported nine global instances where this detection failure occurred. In response, Abbott Trading (Shanghai) Co., Ltd. is undertaking this recall to ensure the integrity of diagnostic results and to uphold patient safety standards. The regulatory framework under which this recall is managed is the NMPA, with the Class II designation indicating a situation where the use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. Detailed information concerning the affected product models, specifications, and batch numbers is available in an attached Medical Device Recall Event Report Form. This recall underscores the continuous need for rigorous quality control and the prompt rectification of product deficiencies in the medical device industry.

Company: https://www.globalkeysolutions.net/companies/abbott-trading-shanghai-co-ltd/851d8fbf-2dac-497e-bf33-820114081013/