NMPA Announces Voluntary Recalls of Medical Devices by Multiple Multinational Companies

On September 5, an announcement released by the National Medical Products Administration showed that multiple multinational companies had initiated voluntary recalls of their medical device products.

 

The notification shows that Abbott Laboratories Trading (Shanghai) Co., Ltd. reported that due to changes in the reportable range of certain test items or sample types for specific models, the manufacturer, Abbott Point of Care Inc., based in the United States, voluntarily recalled its blood gas and biochemical multi-test cartridges (dry electrochemical method) Cartridges for the i-STAT Portable Clinical Analyzers (Registration No.: 20162401411), and blood gas and biochemical eight-test cartridges (dry electrochemical method) i-STAT CG8+ Cartridge (Registration No.: 20182401622). The recall level is classified as a Level III recall. The products involved in this recall were not imported into China.

 

CooperVision Optical Trading (Shanghai) Co., Ltd. reported that due to the potential risk of incomplete sterilization in products with specific batch numbers, the manufacturer CooperVision Inc. is voluntarily recalling its Soft (hydrophilic) Contact Lens (Registration No.: 20213160048). The recall level is classified as a Level Three Recall. The affected products were not imported into China.

 

PHILIPS (China) Investment Co., Ltd. reported that due to a potential software issue affecting the execution of Stop Power Ratio (SPR) generation, which led to incorrect dataset calculations, Philips Medical Systems (Cleveland), Inc., the manufacturer, voluntarily recalled its Radiation Therapy Planning System (Registration No. 20153213194 for Imported Medical Devices in China). The recall level is classified as a Level III recall.

 

According to reports, based on the severity of medical device defects, medical device recalls are divided into:

 

Level 1 Recall: Using thisMedical DeviceMay or already caused seriousHealthHazardous;

 

Level 2 Recall: The use of the medical device may or has already caused temporary or reversible health hazards.

 

Level 3 Recall: The use of the medical device presents a relatively low probability of causing harm but still requires a recall.