# China NMPA Product Recall - Blood glucose test strips (glucose dehydrogenase method)

Source: https://www.globalkeysolutions.net/records/china_product_recall/roche-diagnostics-gmbh/c10e04aa-2750-403c-88fa-b47a7c303fc7/
Source feed: China

> China NMPA product recall for Blood glucose test strips (glucose dehydrogenase method) by Roche Diagnostics GmbH published May 16, 2014. Recall level: . On April 16, 2014, Roche Diagnostics GmbH initiated a global recall, publicly reported by the Nation

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Roche Diagnostics GmbH, Germany, is recalling its blood glucose test strips (glucose dehydrogenase method).
- Company Name: Roche Diagnostics GmbH
- Publication Date: 2014-05-16
- Product Name: Blood glucose test strips (glucose dehydrogenase method)
- Recall Reason: Patients receiving intravenous or intramuscular ceftriaxone (e.g., Rocephin or Cefotrix) may experience falsely low blood glucose readings when using Accu-Chek Mobile blood glucose test strips (glucose dehydrogenase) during treatment. This interfering factor is not mentioned on the product label or instructions.
- Discovering Company: Shanghai Municipal Food and Drug Administration
- Manufacturing Company: Roche Diagnostics GmbH
- Summary: On April 16, 2014, Roche Diagnostics GmbH initiated a global recall, publicly reported by the National Medical Products Administration (NMPA) on May 16, 2014. This action, also involving Roche Diagnostics Products (Shanghai) Co., Ltd. and supported by the Shanghai Municipal Food and Drug Administration, concerned Accu-Chek Mobile blood glucose test strips (Glucose Dehydrogenase Method). The critical issue identified was that these test strips could produce falsely low blood glucose values in patients undergoing intravenous or intramuscular ceftriaxone antibiotic treatment. This significant interfering factor was not disclosed on the product label or instructions, posing a potential safety risk. The NMPA's regulatory framework governs such medical device recalls. In response, Roche Diagnostics GmbH proactively recalled the affected products, which included 47,652 boxes globally and 16,006 imported to China. The company issued recommendations for patients receiving ceftriaxone treatment to discontinue using Accu-Chek Mobile test strips and opt for alternative testing methods. These advisories were communicated via the company's website, hospital notifications, customer hotlines, and updated information on inventory products. Roche also committed to revising the product instructions to incorporate this vital safety information, underscoring its dedication to patient safety and regulatory compliance.

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