4 Recalls Released by NMPA
On September 2, 2020, 4 overseas manufacturers voluntarily recalled 4 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
|
1.
|
Beckman Coulter, Inc.
|
(Nitroso-PSAP method) UIBC
|
Class III
|
The results of the patient sample showed up to 27% positive deviation in the low end of the linear range after the use of specific product models or specific batches.
|
2.
|
Synthes GmbH
|
Cranio-Maxillofacial System
|
Class III
|
The number of etchings on the component “screw clamp” for a specific product model or batch does not match the length of the screw.
|
3.
|
Cook Incorporated
|
Universa Firm Ureteral Stent Set
|
Class II
|
Wrong placement of different batches of a particular model for a particular batch of products.
|
4.
|
Hitachi High-Technologies Corporation
|
HITACHI AUTOMATIC ANALYZER 3100
|
Class II
|
There are software problems in specific models or batches of products
|
