# China NMPA Product Recall - Accu-Chek Aviva test strips (glucose dehydrogenase method)

Source: https://www.globalkeysolutions.net/records/china_product_recall/roche-diagnostics-gmbh/cb6ce0c1-a9ba-442c-970e-278f43389c2e/
Source feed: China

> China NMPA product recall for Accu-Chek Aviva test strips (glucose dehydrogenase method) by Roche Diagnostics GmbH published August 03, 2021. Recall level: Level 2 Recall. The National Medical Products Administration (NMPA) announced on August 3, 2021, that Roche Diagnost

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Roche Diagnostics GmbH is voluntarily recalling its Accu-Chek Aviva test strips (glucose dehydrogenase method).
- Company Name: Roche Diagnostics GmbH
- Publication Date: 2021-08-03
- Product Name: Accu-Chek Aviva test strips (glucose dehydrogenase method)
- Recall Level: Level 2 Recall
- Recall Reason: The test strip tube in the sealed box may be accidentally opened during transportation.
- Discovering Company: Roche Diagnostics Products (Shanghai) Co., Ltd.
- Manufacturing Company: Roche Diagnostics GmbH
- Summary: The National Medical Products Administration (NMPA) announced on August 3, 2021, that Roche Diagnostics GmbH initiated a voluntary Class II recall of specific batches of its Accu-Chek Aviva Blood Glucose Test Strips (Glucose Dehydrogenase Method), registration certificate number 20162403050. This action was reported by Roche Diagnostics Products (Shanghai) Co., Ltd. The primary issue prompting this recall involves a potential problem with product packaging integrity; specifically, there is a possibility that the test strip tube within the sealed product box could accidentally open during transportation. This defect poses a risk to product sterility or efficacy due to potential exposure or damage to the strips before use. The recall level, classified as Class II by the NMPA, indicates that the issue may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. No specific inspection dates were provided in the document, as this was a voluntary recall initiated by the manufacturer. Roche Diagnostics GmbH is responsible for implementing the necessary corrective actions to address the identified packaging defect and prevent recurrence, aligning with NMPA's medical device recall protocols.

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