# China NMPA Product Recall - Fully automated biochemical analyzer

Source: https://www.globalkeysolutions.net/records/china_product_recall/hitachi-high-tech-co-ltd/7170d0e6-8aa3-4385-84be-4ffb1bc38dc2/
Source feed: China

> China NMPA product recall for Fully automated biochemical analyzer by Hitachi High-tech Co., Ltd. published June 29, 2011. Recall level: . The National Medical Products Administration (NMPA) issued a notice on June 29, 2011, regarding a vo

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Hitachi High Technology Co., Ltd. of Japan has recalled its fully automated biochemical analyzer.
- Company Name: Hitachi High-tech Co., Ltd.
- Publication Date: 2011-06-29
- Product Name: Fully automated biochemical analyzer
- Recall Reason: When the analyzer's first module is module D, if there is a delay in the internal communication processing, it may conflict with the closing time of the solenoid valve. Occasionally, the solenoid valve may fail to close, preventing normal sampling and resulting in the sample being diluted by the sprayed cleaning water. Additionally, when reading the sample barcode, if the instrument receives an automatic retest instruction from the host while simultaneously processing the communication readout, this can cause a delay in barcode reading. If this delay exceeds the sample holder's movement cycle, the read sample ID may not have been logged to its original position before the sample holder begins to move, sometimes resulting in the sample being logged to a different position on the same shelf, causing a discrepancy between the sample ID and the actual sample.
- Discovering Company: Hitachi High-Tech (Shanghai) International Trading Co., Ltd. Beijing Branch
- Manufacturing Company: Hitachi High-tech Co., Ltd.
- Summary: The National Medical Products Administration (NMPA) issued a notice on June 29, 2011, regarding a voluntary recall initiated by Hitachi High-Tech Co., Ltd. for specific batches of its Hitachi 7600 Series fully automated biochemical analyzers. The recall addresses two software-related performance issues, though the company assessed they do not pose a serious health hazard given that disease diagnosis relies on a comprehensive clinical assessment.

The first issue involves potential sample dilution, occurring when internal communication delays conflict with the solenoid valve’s closing, leading to cleaning water diluting samples. The second issue pertains to incorrect sample identification, where simultaneous barcode reading and re-inspection instructions can delay processing, potentially logging a sample ID to an incorrect position on the sample rack. While two dilution reports were received from Japan, no related incidents were reported by users in China for either issue.

Hitachi High-Tech Co., Ltd., with its Beijing branch as the responsible unit in China, began implementing software modifications for all 417 affected units sold in the country in October 2010. These corrective actions, involving software updates and confirmations taking approximately two hours per unit, are targeted for completion by the end of September 2011. The NMPA has instructed provincial food and drug administrations to enhance their supervision of these medical devices.

Company: https://www.globalkeysolutions.net/companies/hitachi-high-tech-co-ltd/173ab660-99ec-4a69-a396-576b48294e6b/