# China NMPA Product Recall - Uric acid test strips (dry chemistry method)

Source: https://www.globalkeysolutions.net/records/china_product_recall/roche-diagnostics-gmbh/911858a7-ed58-4bf8-823e-d0d846282cca/
Source feed: China

> China NMPA product recall for Uric acid test strips (dry chemistry method) by Roche Diagnostics GmbH published August 03, 2015. Recall level: Level III. Roche Diagnostics Products (Shanghai) Co., Ltd., working with its manufacturer Roche Diagnostics Gmb

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Roche Diagnostics Products (Shanghai) Co., Ltd. is voluntarily recalling its uric acid test strips (dry chemistry method).
- Company Name: Roche Diagnostics GmbH
- Publication Date: 2015-08-03
- Product Name: Uric acid test strips (dry chemistry method)
- Recall Level: Level III
- Recall Reason: During an internal investigation, Roche Diagnostics headquarters discovered that when using uric acid test strips (dry chemistry method) to test whole blood samples, if the hematocrit value of the sample exceeds 48%, it may lead to erroneous low uric acid test results.
- Discovering Company: Roche Diagnostics Products (Shanghai) Co., Ltd.
- Manufacturing Company: Roche Diagnostics GmbH
- Summary: Roche Diagnostics Products (Shanghai) Co., Ltd., working with its manufacturer Roche Diagnostics GmbH, initiated a voluntary Class III recall for its Uric Acid Test Strips (Dry Chemistry Method) on August 3, 2015. An internal investigation conducted by Roche identified a critical issue: the test strips might yield erroneously low uric acid results when analyzing whole blood samples where the hematocrit value exceeds 48%. This recall specifically impacts product item number 10745103202, with 373 boxes sold in China and 415 globally. Despite receiving no global complaints related to this issue, the company, operating under the National Medical Products Administration (NMPA) framework, proactively undertook this action to safeguard user and patient safety. Corrective measures include updating the product packaging to prominently feature a warning regarding the revised 48% upper limit for hematocrit in whole blood samples. Additionally, Roche Diagnostics issued notification letters to all affected customers, providing comprehensive details of the incident and the necessary actions to be taken, demonstrating a commitment to product integrity and user safety.

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