# China NMPA Product Recall - Electrode boxes for blood gas, electrolyte and biochemical analyzers

Source: https://www.globalkeysolutions.net/records/china_product_recall/roche-diagnostics-gmbh/2107eb36-c32c-4006-8c3f-57938e7fef83/
Source feed: China

> China NMPA product recall for Electrode boxes for blood gas, electrolyte and biochemical analyzers by Roche Diagnostics GmbH published December 10, 2015. Recall level: . The National Medical Products Administration (NMPA) announced a voluntary recall by Roche Diagnostic

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Roche Diagnostics GmbH is recalling electrode cartridges for its blood gas, electrolyte, and biochemistry analyzers.
- Company Name: Roche Diagnostics GmbH
- Publication Date: 2015-12-10
- Product Name: Electrode boxes for blood gas, electrolyte and biochemical analyzers
- Recall Reason: Roche Diagnostics' internal testing revealed that when using certain batches of electrode cartridges for the fully automated blood gas, electrolyte, and biochemical analyzer cobas b 123 POC system, the detection of Na concentration in whole blood samples was affected by the partial pressure of CO₂.
- Discovering Company: Roche Diagnostics Products (Shanghai) Co., Ltd.
- Manufacturing Company: Roche Diagnostics GmbH
- Summary: The National Medical Products Administration (NMPA) announced a voluntary recall by Roche Diagnostics GmbH, initiated on December 10, 2015, regarding specific electrode kits for blood gas, electrolyte, and biochemical analyzers. The distributor, Roche Diagnostics Products (Shanghai) Co., Ltd., reported this action. The core issue, identified through internal testing, revealed that the detection of sodium (Na+) concentration in whole blood samples could be inaccurately influenced by the partial pressure of carbon dioxide (CO₂) when using certain batches of these electrode cartridges with the Roche cobas b 123 system. Despite the recall, Roche Diagnostics confirmed that none of the affected products were sold within the Chinese market. The NMPA, operating under China's regulatory framework for medical devices, requested provincial drug administrations to strengthen their supervision and management of similar products. Importantly, Roche Diagnostics has not received any reports of serious adverse patient events globally related to this issue. Consequently, as no affected units were distributed or sold in China, no direct corrective actions are required for Chinese end-users or healthcare facilities regarding product returns or replacements.

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