# China NMPA Product Recall - Alanine aminotransferase assay kit (rate method)

Source: https://www.keypedia.com/records/china_product_recall/abbott-trading-shanghai-co-ltd/7da8fbdc-d60b-42cf-9432-f0ebb11ef2db
Source feed: China

> China NMPA product recall for Alanine aminotransferase assay kit (rate method) by Abbott Trading (Shanghai) Co., Ltd. published June 18, 2021. Recall level: Level 3 Recall. Abbott Trading (Shanghai) Co., Ltd. initiated a voluntary Class III recall of its Alanine Aminotrans

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Abbott Trading (Shanghai) Co., Ltd. is voluntarily recalling its alanine aminotransferase assay kit (rate method).
- Company Name: Abbott Trading (Shanghai) Co., Ltd.
- Publication Date: 2021-06-18
- Product Name: Alanine aminotransferase assay kit (rate method)
- Recall Level: Level 3 Recall
- Recall Reason: 1. When using alanine aminotransferase (ALT) assay kits nearing their expiration date, linearity standards may not be met. Abbott internal studies have shown that for A-ALT samples with concentrations greater than 1200 U/L, low recovery rates (>10%) are possible. 2. Abbott internal interference studies have shown that patient results may vary by more than 10% when bilirubin concentrations in samples exceed 31 mg/dL.
- Discovering Company: Abbott Trading (Shanghai) Co., Ltd.
- Manufacturing Company: Abbott Trading (Shanghai) Co., Ltd.
- Summary: Abbott Trading (Shanghai) Co., Ltd. initiated a voluntary Class III recall of its Alanine Aminotransferase Assay Kit (Rate Method) on June 18, 2021. The recall stems from two primary issues identified through Abbott's internal testing. Firstly, kits nearing expiration may fail to meet linearity standards, exhibiting a low recovery rate exceeding 10% for A-ALT samples above 1200 U/L. Secondly, internal interference studies revealed that bilirubin concentrations in samples greater than 31 mg/dL could alter patient results by more than 10%. Despite these findings, Abbott has not received any customer complaints or reports of adverse events globally related to these issues. The recall, overseen by the National Medical Products Administration (NMPA) and the Shanghai Municipal Drug Administration, requires Abbott to address these product deficiencies to ensure accuracy and reliability. Detailed information on affected product models and batches is available in the associated Medical Device Recall Event Report Form.

Company: https://www.keypedia.com/companies/abbott-trading-shanghai-co-ltd/851d8fbf-2dac-497e-bf33-820114081013