Five Recalls Released by NMPA

2020-09-08

On September 4, 2020, five overseas manufacturers voluntarily recalled five different medical devices. These recalls include Class II and III Recalls. Detailed information about the manufacturers and recalled products are listed in the table below. Since China NMPA enhances the post-market surveillance, China Med Device can lead manufacturers in compliance with China regulations.

No	Manufacturer	Product Name	Recall Classification	Recall Reason	Link
1	BIOMERIEUX S.A	Chocolate AGAR medium (without antibiotics)	Class III	Certain models and batches of products may produce false negative results in the culture of Staphylococcus and corynebacterium	https://www.nmpa.gov.cn/xxgk/chpzhh /ylqxzhh/ylqxzhhzj/20200904153532178.html
2	Inpeco S. A.	Automatic sample processing system	Class III	The firmware for the specific model and batch interface module has the potential error associated with the sample ID under certain circumstances, resulting in incorrect or delayed results	https://www.nmpa.gov.cn/xxgk/chpzhh /ylqxzhh/ylqxzhhzj/20200904153902151.html
3	Irvine Biomedical，Inc. a St. Jude Medical Company	Inquiry Steerable Diagnostic Catheters	Class II	There are mislabeling of specific models and batches	https://www.nmpa.gov.cn/xxgk/chpzhh /ylqxzhh/ylqxzhhzj/20200904154255172.html
4	Epocal Inc.	epoc BGEM	Class III	Inconsistencies (low bias) in blood glucose results for specific models and batches	https://www.nmpa.gov.cn/xxgk/chpzhh /ylqxzhh/ylqxzhhzj/20200904154153158.html
5	Inpeco S.A.	ACCELERATOR a3600	Class III	Firmware with interface module (IM) in a particular model or batch may incorrectly associate sample ID, resulting in incorrect or delayed results	https://www.nmpa.gov.cn/xxgk/chpzhh /ylqxzhh/ylqxzhhzj/20200904154340172.html