# China NMPA Product Recall - Novel Coronavirus 2019-nCoV Nucleic Acid Detection Kit (Fluorescent PCR Method)

Source: https://www.globalkeysolutions.net/records/china_product_recall/jiangsu-shushi-biotechnology-co-ltd/846c81ae-cfde-4f69-8c2d-55ac4edc844d/
Source feed: China

> China NMPA product recall for Novel Coronavirus 2019-nCoV Nucleic Acid Detection Kit (Fluorescent PCR Method) by Jiangsu Shushi Biotechnology Co., Ltd. published March 22, 2021. Recall level: Level 3 Recall. Jiangsu ShuoShi Biotechnology Co., Ltd. has initiated a voluntary Level III recall for its Novel Cor

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Jiangsu ShuoShi Biotechnology Co., Ltd. has voluntarily recalled its 2019-nCoV nucleic acid detection kit (fluorescent pCR method).
- Company Name: Jiangsu Shushi Biotechnology Co., Ltd.
- Publication Date: 2021-03-22
- Product Name: Novel Coronavirus 2019-nCoV Nucleic Acid Detection Kit (Fluorescent PCR Method)
- Recall Level: Level 3 Recall
- Recall Reason: During transportation, the product experienced temperature anomalies at certain points. Although the company's research and development team has fully verified that this situation does not affect product quality, considering the potential risks, the relevant batches of products are being proactively recalled.
- Discovering Company: Jiangsu ShuoShi Biotechnology Co., Ltd.
- Manufacturing Company: Jiangsu Shushi Biotechnology Co., Ltd.
- Summary: Jiangsu ShuoShi Biotechnology Co., Ltd. has initiated a voluntary Level III recall for its Novel Coronavirus 2019-nCoV Nucleic Acid Detection Kit (Fluorescent PCR Method). This measure was reported to the relevant Provincial Drug Administration, operating under the National Medical Products Administration (NMPA) regulatory framework in China. The primary reason for the recall was the detection of abnormal temperatures during the transportation of the kits. Although the company's internal research and verification concluded that product quality was not adversely affected by these temperature excursions, a proactive decision was made to recall the product due to the identification of potential risks. The recall specifically targets various batch numbers of the 50 tests/box kit, which are used for the in vitro qualitative detection of the novel coronavirus in clinical samples like nasopharyngeal swabs and sputum. As part of the required corrective actions, Jiangsu ShuoShi Biotechnology Co., Ltd. is notifying all affected customers to return their inventory of the implicated batches. Upon receipt, the company will undertake the destruction of all returned products to ensure no potentially compromised items remain in circulation, upholding product safety and integrity.

Company: https://www.globalkeysolutions.net/companies/jiangsu-shushi-biotechnology-co-ltd/920ad291-9a50-44ad-9f9d-7105866cacb9/