China NMPA Product Recall - Fully automated chemiluminescence immunoassay analyzer

Abbott Trading (Shanghai) Co., Ltd. initiated a voluntary Class III recall of its fully automated chemiluminescence immunoassay analyzer (Registration Certificate No.: 20183400031). This action was publicly reported by the National Medical Products Administration (NMPA) on February 20, 2020, with additional details provided by the Shanghai Municipal Drug Administration website on April 3, 2020.

The recall addresses a potential software issue within the current version of the Alinity ci-series software. The core problem arises when diagnostic procedure 1525, which involves a processing channel sensor test, is executed and the RV cup sensor option is selected. Under these specific conditions, the system may erroneously load up to six previously used RV cups onto the processing channel. This flaw could lead to the unintended reuse of these spent cups for processing new samples, creating a significant risk of producing inaccurate or erroneous diagnostic test results.

Operating under the NMPA's regulatory oversight, Abbott Trading (Shanghai) Co., Ltd. is undertaking this recall to prevent potential diagnostic inaccuracies. The company is actively working to resolve the software defect and mitigate any associated risks. Comprehensive details regarding the affected product models, specifications, and specific batches are available in the accompanying "Medical Device Recall Event Report Form."