China NMPA Product Recall - Streptococcal identification strips RapID STR System

Remel Inc., a medical device manufacturer, has initiated a voluntary Class III recall of its RapID STR System strips. This action was reported to the National Medical Products Administration (NMPA) on July 4, 2023, by Thermo Fisher Scientific (China) Co., Ltd., the distributor. The recall was prompted by an internal technical investigation revealing a critical defect: a specific batch of these Streptococcus identification strips produces an erroneous positive reaction for two bacterial species that should register as negative. This significant deviation in expected performance poses a risk to the accuracy of diagnostic testing. The regulatory oversight for this recall falls under the NMPA in China. While the document does not specify any inspection dates, the recall is a direct result of the manufacturer's internal quality controls. The required action involves the immediate and voluntary recall of the affected product batches. Specific details regarding the models, specifications, and batch numbers of the involved products are provided in an attached "Medical Device Recall Event Report Form" to ensure comprehensive identification and removal of the faulty strips from circulation, thereby preventing further diagnostic inaccuracies.