# China NMPA Product Recall - Mycobacterium tuberculosis complex and drug resistance gene mutation detection kit (PCR-linear hybridization enzyme colorimetric method)

Source: https://www.globalkeysolutions.net/records/china_product_recall/roche-diagnostics-products-shanghai-co-ltd/8dd0d940-1014-4dac-bf9f-e51cb9836644/
Source feed: China

> China NMPA product recall for Mycobacterium tuberculosis complex and drug resistance gene mutation detection kit (PCR-linear hybridization enzyme colorimetric method) by Roche Diagnostics Products (Shanghai) Co., Ltd. published December 30, 2021. Recall level: Level 3 Recall. BioMérieux Diagnostics (Shanghai) Co., Ltd. initiated a Class III voluntary recall for its Mycobacte

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: bioMérieux Diagnostics Products (Shanghai) Co., Ltd. is voluntarily recalling its Mycobacterium tuberculosis complex and drug resistance gene mutation detection kit (PCR-linear hybridization enzyme colorimetric method).
- Company Name: Roche Diagnostics Products (Shanghai) Co., Ltd.
- Publication Date: 2021-12-30
- Product Name: Mycobacterium tuberculosis complex and drug resistance gene mutation detection kit (PCR-linear hybridization enzyme colorimetric method)
- Recall Level: Level 3 Recall
- Recall Reason: The products in question were affected because German company HeinLife Science GmbH received complaints and confirmed that in rare cases, such as when PCR amplification was absent or invalid, the amplification control (AC) might still show a weak positive signal, thus causing the band of the positive sample to be interpreted as a false negative.
- Discovering Company: bioMérieux Diagnostics Products (Shanghai) Co., Ltd.
- Manufacturing Company: Roche Diagnostics Products (Shanghai) Co., Ltd.
- Summary: BioMérieux Diagnostics (Shanghai) Co., Ltd. initiated a Class III voluntary recall for its Mycobacterium tuberculosis complex and drug resistance gene mutation detection kit (Registration Certificate No.: 20173405235), as reported on December 30, 2021, by the Shanghai Municipal Drug Administration, operating under the broader regulatory framework of the National Medical Products Administration (NMPA). The recall was prompted by confirmed issues originating from complaints received by HeinLife Sciences GmbH in Germany. Investigations revealed that, in rare circumstances, the kit's amplification control (AC) could display a weak positive signal even when PCR amplification was absent or invalid. This critical flaw presents a risk of misinterpreting actual positive samples as false negatives, potentially leading to incorrect clinical diagnoses. Although no related complaints had been reported in mainland China at the time of the announcement, the company proactively undertook the recall to mitigate potential diagnostic inaccuracies. BioMérieux Diagnostics (Shanghai) Co., Ltd. is required to furnish additional details concerning the specific affected product models, specifications, and batches within a comprehensive Medical Device Recall Event Report Form. This decisive action highlights the ongoing commitment to product quality and patient safety within the medical device sector.

Company: https://www.globalkeysolutions.net/companies/roche-diagnostics-products-shanghai-co-ltd/9b830c5b-8305-4f55-9e76-759151e7c7a9/