Testing Kits recalled by Siemens Healthcare Diagnostics(Shanghai) Co., Ltd

放大字体  缩小字体 Release Date:2018-02-24 Source:CFDA web Author:CFDA Views:46

After an internal investigation, Siemens Healthcare Diagnostics(Shanghai) Co., Ltd confirmed that their cyclosporin determination kit (chemiluminescence) and other Kits may be biotin interfered so they have taken the initiative to recall products as below:

Cyclosporin Assay Kit (Chemiluminescence) (Registration No .: Guozhong Injection 20152400123)

Dehydroepiandrosterone Sulfate Assay Kit (Chemiluminescence) No .: Guozhu injection 20152400122) 

Folic acid assay kit (direct chemiluminescence) (registration number: Guozhu injection 20162404412)

hepatitis B virus core antibody IgM assay kit (chemiluminescence method) ( Registration No .: State injection into 20153400555)

Recall level is three.  for more information on product models, specifications and batches. please Check "Medical Device Recall Incident Report Form" as attached

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