SFDA inspection turns up flawed IVD medical devices
Shanghai. November 1. INTERFAX-CHINA - A total of six batches of in vitro diagnostic (IVD) medical devices failed a recent sampling inspection by the State Food and Drug Administration (SFDA), the administration announced Oct. 29.
According to the announcement, the SFDA inspected a total of 196 batches of IVDs from 68 manufacturers and one import agent nationwide. The lots that failed the inspection were produced by three IVD manufacturers.
Shandong Clinsciences Biotech Co. Ltd. performed poorest in the inspection, with two batches of total protein (TP) assay kits and one batch of albumin (ALB) assay kit failing as a result of an error in absorbance of blank solution.
Germany's Biotest AG also failed the inspection, with two batches of RhD(IgM)blood grouping reagent kit (monoclonal antibody) rejected due to improper weight.
One batch of Beijing Chemclin Biotech Co Ltd.'s diagnostic kit for Alpha-feto-protein (AFP) also failed testing.