# China NMPA Product Recall - Blood gas testing reagent kit; biochemistry module calibration solution

Source: https://www.globalkeysolutions.net/records/china_product_recall/roche-diagnostics-gmbh/c11b0639-dcc6-40c7-a7b0-f488e35e0ddf/
Source feed: China

> China NMPA product recall for Blood gas testing reagent kit; biochemistry module calibration solution by Roche Diagnostics GmbH published July 24, 2015. Recall level: Level III. Roche Diagnostics Products (Shanghai) Co., Ltd. initiated a voluntary Class III recall on July 24, 2

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Roche Diagnostics Products (Shanghai) Co., Ltd. is voluntarily recalling blood gas analysis kits and biochemistry module calibration solutions.
- Company Name: Roche Diagnostics GmbH
- Publication Date: 2015-07-24
- Product Name: Blood gas testing reagent kit; biochemistry module calibration solution
- Recall Level: Level III
- Recall Reason: The problem with the connection chip caused the instrument to display an error message: "Connection chip error".
- Discovering Company: Roche Diagnostics Products (Shanghai) Co., Ltd.
- Manufacturing Company: Roche Diagnostics GmbH
- Summary: Roche Diagnostics Products (Shanghai) Co., Ltd. initiated a voluntary Class III recall on July 24, 2015, under the oversight of the National Medical Products Administration (NMPA). The recall addresses a critical issue involving certain batches of its Blood Gas Detection Kits and Biochemistry Module Calibration Solutions. The primary concern is a 'Connection Chip Error' message appearing on instruments due to a problem with the internal connection chip in these products. This malfunction could hinder the accurate calibration and quantitative detection of various analytes, including sodium, potassium, calcium, pH, and glucose, essential for patient diagnostics. The affected products include specific models and batches, with 645 boxes sold in China, though the recall's scope is global. To mitigate the impact on healthcare providers and ensure patient safety, Roche Diagnostics outlined specific corrective actions. The company committed to dispatching notification letters to all customers who received the identified affected batches, providing detailed information about the issue and necessary steps. Furthermore, Roche pledged to supply affected customers with either one unaffected replacement batch or four affected batches as temporary backups, aiming to prevent any disruptions in critical medical testing services. This proactive measure by Roche demonstrates its commitment to product quality and patient care.

Company: https://www.globalkeysolutions.net/companies/roche-diagnostics-gmbh/2a33a337-c39d-4329-b659-c812f690f94b/