BD, bioMérieux, and Abbott Issue Medical Device Recalls in China

China Economic Net, July 18 (Reporter Hanlu) -- On July 18, the website of the National Medical Products Administration announced several medical device recalls involving well-known companies such as BD, bioMérieux, and Abbott.

BD Medical Devices (Shanghai) Co., Ltd. reported that due to issues involving specific models and specific batches of products, there were problems with tubing damage or blood leakage during use. The manufacturer, Becton Dickinson and Company, voluntarily recalled the Push Button Blood Collection Set (registration certificate number: Guo Med Reg No. 20163222182). The recall level is Class II.

BioMérieux Diagnostics (Shanghai) Co., Ltd. reported that due to issues with specific models and specific batches of products, there may be delays or no results when processing Legionella nucleic acid. The manufacturer, BioMérieux S.A. from France, has initiated a Level 2 recall of the NucliSENS easyMAG Accessory Products (registration certificate code: National Medical Device Filing No. 20180501), which are used for nucleic acid extraction or purification.

Abbott Medical (Shanghai) Co., Ltd. reported that due to issues involving specific models and specific batches of products, there are errors in the information stored in the rewritable memory (EEPROM). Abbott Medical, the manufacturer, is voluntarily recalling the TactiCathTM Contact Force Ablation Catheter, Sensor EnabledTM (Registration Certificate No.: Guo Med Reg In 20203010469), a disposable magnetically and electrically positioned pressure monitoring ablation catheter. The recall level is Class III.