# China NMPA Product Recall - Sample processing system

Source: https://www.globalkeysolutions.net/records/china_product_recall/abbott-trading-shanghai-co-ltd/0145047e-a102-4d2d-95a7-36f0db03668f/
Source feed: China

> China NMPA product recall for Sample processing system by Abbott Trading (Shanghai) Co., Ltd. published April 14, 2020. Recall level: Level 3 Recall. Abbott Trading (Shanghai) Co., Ltd. initiated a Class III voluntary recall of its sample processing 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Abbott Trading (Shanghai) Co., Ltd. has proactively recalled its sample processing system.
- Company Name: Abbott Trading (Shanghai) Co., Ltd.
- Publication Date: 2020-04-14
- Product Name: Sample processing system
- Recall Level: Level 3 Recall
- Recall Reason: Firmware version issues in the centrifuge module of the sample processing system may cause the test tube loading algorithm to fail to meet the balance specifications, potentially leading to load imbalance. The ARCHITECT c system interface module may generate a total timeout error (code 7083) under certain operations. When the clot detection error occurs in the dispensing module, the error recovery procedure may cause distilled water to backflow into the original tube.
- Discovering Company: Abbott Trading (Shanghai) Co., Ltd.
- Manufacturing Company: Abbott Trading (Shanghai) Co., Ltd.
- Summary: Abbott Trading (Shanghai) Co., Ltd. initiated a Class III voluntary recall of its sample processing system (Registration Certificate No.: 20161009), as reported by the National Medical Products Administration (NMPA) on April 14, 2020, and published on July 6, 2020. The recall stems from two critical issues identified in the system's firmware.

Firstly, specific firmware versions (CM_1-7-0.H86, CM_1-7-1.H86) in the centrifuge modules (Inpeco model FLX-202) contain a tube loading algorithm that does not adhere to balancing instructions. This deficiency can lead to load imbalances, potentially causing a "total timeout error (code 7083)." This error is particularly likely if the ARCHITECT c system interface module is active and the sample turntable lid remains open, or if multiple samples run for extended periods.

Secondly, dispensing modules with older firmware versions (AQMb_3-3-0.H86, AQMa_3-1-1-8.H86, AQMb_3-1-1-8.H86) exhibit a flaw in their clot detection error recovery. If a clot detection error (code EOEO) occurs, the system's procedure for returning sample volume could inadvertently cause distilled water from the hydraulic system to backflow into the original sample tube.

Abbott Trading (Shanghai) Co., Ltd. is taking required action by recalling the affected devices. Further specifics on impacted product models, specifications, and batches are available in the attached "Medical Device Recall Event Report Form." This proactive measure ensures compliance with NMPA regulations and patient safety standards.

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