# 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/5003fbf8-b606-4cd7-a63e-aaf8ec0dfaac/
Source feed: China

> China NMPA product recall for Electrode boxes for blood gas, electrolyte and biochemical analyzers by Roche Diagnostics GmbH published August 23, 2016. Recall level: . Roche Diagnostics GmbH initiated a voluntary recall in August 2016 for specific electrode kits used 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Roche Diagnostics GmbH is recalling electrode cartridges for its blood gas, electrolyte, and biochemical analyzers.
- Company Name: Roche Diagnostics GmbH
- Publication Date: 2016-08-23
- Product Name: Electrode boxes for blood gas, electrolyte and biochemical analyzers
- Recall Reason: The electrode boxes for blood gas, electrolyte, and biochemical analyzers with the above serial numbers will be affected by the partial pressure of CO₂ when detecting Na concentration in whole blood samples. Customers who need to test Na concentration in whole blood samples should avoid using products with the above-mentioned affected serial numbers.
- Discovering Company: Roche Diagnostics Products (Shanghai) Co., Ltd.
- Manufacturing Company: Roche Diagnostics GmbH
- Summary: Roche Diagnostics GmbH initiated a voluntary recall in August 2016 for specific electrode kits used with blood gas, electrolyte, and biochemical analyzers. The affected product, identified as cobas b 123 Sensor Cartridge (Item No. 05170478001, Lot No. 21560883), was found to have a performance issue where the partial pressure of CO2 affects the accuracy of sodium (Na) concentration detection in whole blood samples. This could potentially lead to inaccurate patient results. The recall was initiated following an internal investigation by Roche Diagnostics headquarters. Although the issue could impact sodium concentration readings, Roche Diagnostics reported no globally confirmed serious adverse events related to these specific product batches at the time of the report. Under the oversight of the National Medical Products Administration (NMPA) of China, Roche Diagnostics Products (Shanghai) Co., Ltd., the local distributor, confirmed that the identified affected batches of electrode kits were neither imported nor sold within the Chinese market. Consequently, the company stated that no direct corrective actions were required within China regarding these specific recalled products. However, the NMPA requested all provincial Food and Drug Administrations to enhance their supervision and management of similar medical devices to ensure public safety.

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