# China NMPA Product Recall - ARCHITECT iGentamicin Reagent Kit (Chemiluminescent Microparticle Immunoassay)

Source: https://www.globalkeysolutions.net/records/china_product_recall/abbott-trading-shanghai-co-ltd/ea4d32ad-0130-4912-87fe-7e5869b383c9/
Source feed: China

> China NMPA product recall for ARCHITECT iGentamicin Reagent Kit (Chemiluminescent Microparticle Immunoassay) by Abbott Trading (Shanghai) Co., Ltd. published April 30, 2020. Recall level: Level 3 Recall. Abbott Trading (Shanghai) Co., Ltd. initiated a voluntary Class III recall of its ARCHITECT iGentami

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Abbott Trading (Shanghai) Co., Ltd. is voluntarily recalling its ARCHITECT iGentamicin Reagent Kit (a chemiluminescent microparticle immunoassay kit).
- Company Name: Abbott Trading (Shanghai) Co., Ltd.
- Publication Date: 2020-04-30
- Product Name: ARCHITECT iGentamicin Reagent Kit (Chemiluminescent Microparticle Immunoassay)
- Recall Level: Level 3 Recall
- Recall Reason: If the ARCHITECT gentamicin test is followed directly by the ARCHITECT high-sensitivity troponin I test, the ARCHITECT high-sensitivity troponin I samples may show interactions. Patient results may be affected.
- 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 ARCHITECT iGentamicin Reagent Kit (Chemiluminescent Microparticle Immunoassay) on April 30, 2020, as reported by the National Medical Products Administration (NMPA). The recall stems from Abbott's internal discovery of a potential interaction issue. The company identified that if the ARCHITECT gentamicin test is conducted immediately following the ARCHITECT high-sensitivity intraocular calcium-I test, samples from the latter may exhibit an interaction. This interaction could potentially compromise the accuracy of patient results obtained from the high-sensitivity intraocular calcium-I test. Despite this technical finding, Abbott confirmed that it had not received any related complaints or adverse event reports globally concerning this specific issue. The company is taking proactive measures to address the potential for inaccurate diagnostic outcomes by recalling the affected product. The regulatory framework governing this action is the NMPA, overseeing medical device safety within China. Abbott's required action involves the immediate withdrawal of the ARCHITECT iGentamicin Reagent Kit from the market to mitigate any risk to patient care, with further details provided in an attached Medical Device Recall Event Report Form.

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