# China NMPA Product Recall - Fully automated chemiluminescence immunoassay analyzer

Source: https://www.globalkeysolutions.net/records/china_product_recall/abbott-trading-shanghai-co-ltd/0f9dca18-3167-4f1e-be71-5747bda64ead/
Source feed: China

> China NMPA product recall for Fully automated chemiluminescence immunoassay analyzer by Abbott Trading (Shanghai) Co., Ltd. published June 25, 2019. Recall level: Level 2 Recall. Abbott Trading (Shanghai) Co., Ltd. initiated a voluntary Level II recall of its fully automated che

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Abbott Trading (Shanghai) Co., Ltd. is voluntarily recalling its fully automated chemiluminescence immunoassay analyzer.
- Company Name: Abbott Trading (Shanghai) Co., Ltd.
- Publication Date: 2019-06-25
- Product Name: Fully automated chemiluminescence immunoassay analyzer
- Recall Level: Level 2 Recall
- Recall Reason: An issue exists with the Alinity ci-series software version on the market: if the system abnormally transitions from a "processing" state to a "stopped" state and then back to a "standby" state, the reaction vessel (RV vessel) may be reused, leading to incorrect subsequent test results.
- Discovering Company: Abbott Trading (Shanghai) Co., Ltd.
- Manufacturing Company: Abbott Trading (Shanghai) Co., Ltd.
- Summary: Abbott Trading (Shanghai) Co., Ltd. initiated a voluntary Level II recall of its fully automated chemiluminescence immunoassay analyzer, as announced on June 25, 2019. This action, reported by the Shanghai Food and Drug Administration and the National Medical Products Administration, addresses a critical software issue identified in the Alinity ci-series. The problem arises when the system transitions abnormally from "processing" to "stopped" and subsequently to "standby." Under these specific conditions, there is a risk that reaction cups (RV cups) may be inadvertently reused. Such reuse has the potential to compromise the accuracy of subsequent test results, posing a significant concern for patient diagnostics and safety. The company proactively reported this defect and is undertaking the recall to mitigate the risk associated with these devices. Details regarding the specific product models, specifications, and affected batches are available in the accompanying Medical Device Recall Event Report Form. This recall underscores the importance of stringent software validation and immediate corrective actions in medical device manufacturing to ensure product reliability and patient well-being.

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