# China NMPA Product Recall - Electrolyte analyzer

Source: https://www.globalkeysolutions.net/records/china_product_recall/roche-diagnostics-products-shanghai-co-ltd/b055636c-16fb-47a5-8e3b-ca96f7ccece3/
Source feed: China

> China NMPA product recall for Electrolyte analyzer by Roche Diagnostics Products (Shanghai) Co., Ltd. published February 03, 2021. Recall level: Level 2 Recall. Roche Diagnostics Products (Shanghai) Co., Ltd. initiated a voluntary Class II recall of its electro

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Roche Diagnostics Products (Shanghai) Co., Ltd. is voluntarily recalling its electrolyte analyzers.
- Company Name: Roche Diagnostics Products (Shanghai) Co., Ltd.
- Publication Date: 2021-02-03
- Product Name: Electrolyte analyzer
- Recall Level: Level 2 Recall
- Recall Reason: Roche Diagnostics' internal validation study found that when the unit for the calcium ion test is set to mg/dL (configured service code MGL) and the measured calcium ion value is below the normal range, the arrow direction displayed on the screen may be incorrect. The numerical results displayed on the screen are correct, and the printed results and arrow direction are correct. Only the calcium ion test is affected by this issue.
- Discovering Company: Roche Diagnostics Products (Shanghai) Co., Ltd.
- Manufacturing Company: Roche Diagnostics Products (Shanghai) Co., Ltd.
- Summary: Roche Diagnostics Products (Shanghai) Co., Ltd. initiated a voluntary Class II recall of its electrolyte analyzer on February 3, 2021, as reported by the National Medical Products Administration (NMPA) and the Shanghai Municipal Drug Administration. The recall stems from an internal validation study revealing a display anomaly: when the calcium ion test unit was set to mg/dL and the measured value fell below the normal range, the arrow direction on the screen might incorrectly indicate the trend. Importantly, the actual numerical results displayed on the screen were accurate, and all printed output, including the arrow direction, was correct. This issue exclusively impacted the calcium ion test, and Roche had not received any customer complaints regarding the matter prior to the recall. The company's proactive measure ensures product integrity, with specific affected models and batches detailed in the associated Medical Device Recall Event Report Form. This voluntary action underscores adherence to regulatory standards for medical device safety.

Company: https://www.globalkeysolutions.net/companies/roche-diagnostics-products-shanghai-co-ltd/9b830c5b-8305-4f55-9e76-759151e7c7a9/