China NMPA Product Recall - RapID NF Plus System for Identifying Non-Fermenting Gram-Negative Bacteria

Thermo Fisher Scientific (China) Co., Ltd., under the oversight of the National Medical Products Administration (NMPA), initiated a voluntary Class III recall for specific batches of its "Non-Fermenting Gram-Negative Bacteria Identification Strip RapID NF Plus System" (Registration Certificate No.: 20152402797). This recall was publicly announced on June 3, 2021. The primary issue identified involved batch number 158548, where the product exhibited anomalous "positive reactions in the NO3 wells" of the test plate when used with control bacterial strains ATCC 19606 (Acinetobacter baumannii) and ATCC 13253 (Elizabeth meningoseptica). This deviation indicated a performance inconsistency in the diagnostic strips. Despite this identified product performance issue, a thorough risk assessment concluded that the use of the affected strips is not expected to lead to immediate or long-term adverse health consequences for patients. The clinical risk associated with this issue was deemed minor. Consequently, Thermo Fisher Scientific (China) Co., Ltd. proactively undertook the recall to uphold product quality and ensure adherence to established regulatory standards. Further details regarding the specific affected products are documented in the "Medical Device Recall Event Report Form".