# China NMPA Product Recall - Ammonia Assay Kit (Glutamate Dehydrogenase Method)

Source: https://www.globalkeysolutions.net/records/china_product_recall/sentinel-ch-spa/937debab-5f4c-4ac6-a038-0011d7e7b027/
Source feed: China

> China NMPA product recall for Ammonia Assay Kit (Glutamate Dehydrogenase Method) by Sentinel CH SPA published September 28, 2015. Recall level: Level III. Abbott Trading (Shanghai) Co., Ltd., in coordination with the National Medical Products Administrati

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Abbott Trading (Shanghai) Co., Ltd. is voluntarily recalling its ammonia assay kits (glutamate dehydrogenase method).
- Company Name: Sentinel CH SPA
- Publication Date: 2015-09-28
- Product Name: Ammonia Assay Kit (Glutamate Dehydrogenase Method)
- Recall Level: Level III
- Recall Reason: Due to a manufacturing defect, affected batches of products reported values below the linear lower limit when testing heparin plasma samples, resulting in users being unable to obtain sample results and delays of several hours or even days.
- Discovering Company: Abbott Trading (Shanghai) Co., Ltd.
- Manufacturing Company: Sentinel CH SPA
- Summary: Abbott Trading (Shanghai) Co., Ltd., in coordination with the National Medical Products Administration (NMPA), initiated a voluntary Level III recall of its Ammonia Assay Kit (Glutamate Dehydrogenase Method) on September 28, 2015. The recall, also involving manufacturer Sentinel CH SpA, was prompted by a critical manufacturing defect affecting product batch 42072L101. This defect caused the affected kits to report values below the lower linear limit when testing heparin plasma samples, rendering accurate patient results unobtainable and leading to significant delays in test outcomes. The scope of this issue was global, though only two boxes of the affected products were sold/imported into China. To address this serious concern, Abbott Trading (Shanghai) Co., Ltd. has taken immediate corrective actions. Customers were promptly notified to cease using the compromised product. All recalled kits are slated for destruction to prevent any further use and potential misdiagnosis. This proactive measure underscores the company's commitment to product quality and patient safety under the regulatory oversight of the NMPA.

Company: https://www.globalkeysolutions.net/companies/sentinel-ch-spa/5d7399c8-66cc-4fce-a300-5eb9695e485a/