# China NMPA Product Recall - Specialty Protein Dry Immunophenochromatography Analyzer Alere Afinion AS100 Analyzer

Source: https://www.globalkeysolutions.net/records/china_product_recall/abbott-diagnostics-technologies-as-norway/cd1607cf-8f67-4a34-899f-ff68a6592f29/
Source feed: China

> China NMPA product recall for Specialty Protein Dry Immunophenochromatography Analyzer Alere Afinion AS100 Analyzer by Abbott Diagnostics Technologies AS (Norway) published January 27, 2021. Recall level: Level 3 Recall. On January 27, 2021, the National Medical Products Administration (NMPA) announced a voluntary Class

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Abbott (Shanghai) Diagnostics Products Sales Co., Ltd. is voluntarily recalling the Alere Afinion AS100 Analyzer (Special Protein Dry Immunochromatography Analyzer).
- Company Name: Abbott Diagnostics Technologies AS (Norway)
- Publication Date: 2021-01-27
- Product Name: Specialty Protein Dry Immunophenochromatography Analyzer Alere Afinion AS100 Analyzer
- Recall Level: Level 3 Recall
- Recall Reason: We received a complaint that the power cord and power adapter included with the analyzer were causing electrostatic discharge and sparks, resulting in damage to the power cord and power adapter and preventing them from working properly.
- Discovering Company: Abbott (Shanghai) Diagnostics Products Sales Co., Ltd.
- Manufacturing Company: Abbott Diagnostics Technologies AS (Norway)
- Summary: On January 27, 2021, the National Medical Products Administration (NMPA) announced a voluntary Class III recall initiated by Abbott (Shanghai) Diagnostic Products Sales Co., Ltd. This action concerns the Alere Afinion AS100 Analyzer for Special Protein Dry Immunochromatography. The manufacturer, Abbott Diagnostics Technologies AS, decided to proceed with the recall following numerous customer complaints. These complaints specifically detailed incidents of electrostatic discharge and sparks originating from the power cord and power adapter supplied with the analyzer. Such occurrences led to reported damage to these essential components, subsequently causing the device to malfunction. Under the oversight of the NMPA, Abbott Diagnostics Technologies AS has proactively undertaken a voluntary recall of the affected "Special Protein Dry Immunochromatographic Analyzer." This measure directly addresses the product quality and safety concerns raised by these reported defects, ensuring device reliability and patient safety. Further details, including specific product models and batch numbers, are available in the comprehensive Medical Device Recall Event Report Form, which was issued alongside the official announcement.

Company: https://www.globalkeysolutions.net/companies/abbott-diagnostics-technologies-as-norway/88fffc1b-d1cf-4343-95c7-e7fdff35560d/