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

Source: https://www.globalkeysolutions.net/records/china_product_recall/roche-diagnostics-gmbh/b60646e9-85f7-4c49-a044-f34f43a5b7fb/
Source feed: China

> China NMPA product recall for Uric acid test strips (dry chemistry method) by Roche Diagnostics GmbH published April 21, 2016. Recall level: Level III. Roche Diagnostics Products (Shanghai) Co., Ltd., acting on behalf of manufacturer Roche Diagnostics 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Roche Diagnostics Products (Shanghai) Co., Ltd. has initiated a voluntary recall of its uric acid test strips.
- Company Name: Roche Diagnostics GmbH
- Publication Date: 2016-04-21
- Product Name: Uric acid test strips (dry chemistry method)
- Recall Level: Level III
- Recall Reason: 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 an erroneous low uric acid test result.
- Discovering Company: Roche Diagnostics Products (Shanghai) Co., Ltd.
- Manufacturing Company: Roche Diagnostics GmbH
- Summary: Roche Diagnostics Products (Shanghai) Co., Ltd., acting on behalf of manufacturer Roche Diagnostics GmbH (Germany), initiated a voluntary Class III recall for its Uric Acid Test Strips (dry chemical method, Item Number: 10745103202). This action followed an internal investigation, reported on February 14, 2016, and subsequently publicized by the National Medical Products Administration (NMPA) on April 21, 2016. The core issue identified was that whole blood samples with a hematocrit value exceeding 48% could lead to erroneously low uric acid test results, contradicting the previous instruction's stated upper limit of 55%.

Although no related complaints had been reported globally, Roche Diagnostics proactively recalled 62 affected boxes sold in China, encompassing a global scope. Required actions include sending notification letters to all customers using the affected products to inform them of the situation and necessary precautions. Additionally, Roche is updating the product packaging with an important notice, adjusting the hematocrit upper limit for whole blood samples to 48%. This temporary update will remain until the comprehensive product instructions are fully revised, a process that began with batches produced from LOT:135769 in April 2016.

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