# China NMPA Product Recall - Mycobacterium tuberculosis rpoB gene and mutation detection kit (real-time fluorescence PCR method) MTB/RIF Assay

Source: https://www.globalkeysolutions.net/records/china_product_recall/cepheid-ab-sweden/92eb01c2-6d05-41b2-8a40-50a9d4eeedf9/
Source feed: China

> China NMPA product recall for Mycobacterium tuberculosis rpoB gene and mutation detection kit (real-time fluorescence PCR method) MTB/RIF Assay by Cepheid AB, Sweden published November 14, 2022. Recall level: Level 3 Recall. The National Medical Products Administration (NMPA) published a Level III voluntary recall notice on

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Cepheid AB Mycobacterium tuberculosis rpoB gene and mutation detection kit (real-time fluorescence PCR method) MTB/RIF Assay (Sweden) voluntarily recalled.
- Company Name: Cepheid AB, Sweden
- Publication Date: 2022-11-14
- Product Name: Mycobacterium tuberculosis rpoB gene and mutation detection kit (real-time fluorescence PCR method) MTB/RIF Assay
- Recall Level: Level 3 Recall
- Recall Reason: There is an issue with incorrect expiration date marking.
- Discovering Company: CePai (Shanghai) Trading Co., Ltd.
- Manufacturing Company: Cepheid AB, Sweden
- Summary: The National Medical Products Administration (NMPA) published a Level III voluntary recall notice on November 14, 2022, concerning a diagnostic product manufactured by Cepheid AB and reported by Cepheid (Shanghai) Trading Co., Ltd. The affected product is the Mycobacterium tuberculosis rpoB gene and mutation detection kit (real-time fluorescence PCR method) MTB/RIF Assay, identified by Registration Certificate No. 20173406215. The core issue prompting this recall was an error in the expiration date labeling found on a specific model and batch of the kits. Accurate expiration dating is critical for medical devices to ensure their efficacy and safety throughout their intended shelf life, preventing the use of potentially compromised products. Under the regulatory framework of the NMPA, Cepheid initiated this voluntary recall. A Level III recall signifies that while the product violation is not likely to cause adverse health consequences, corrective action is necessary to address the non-compliance. The company is committed to rectifying this labeling discrepancy to uphold product quality standards. Further specifics regarding the exact models, specifications, and affected batches are detailed in the official "Medical Device Recall Event Report Form" accompanying the NMPA's announcement. This action underscores the importance of stringent quality control in medical device manufacturing and regulatory oversight to safeguard public health.

Company: https://www.globalkeysolutions.net/companies/cepheid-ab-sweden/d479bc23-6169-4f52-8df1-3c657b0d02d7/