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Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 070 03 17 000
Date submitted: 3/19/2017
Manufacturer:Immucor GmbH
Device Type:Panocell-20
Description:IVDs, Blood Transfusion
Medical Device Identifier:Lot No.: 52872
Ref: 0005020
UDI : 10888234001843
Reason of Field Safety Corrective Action:Immucor is issuing this product notification regarding the V antigen typing for donor E1011, Cell #11 of Panocell-20, Lot 52872. Additional DNA testing of donor E1011 has confirmed the donor as V—, instead of Vi- as indicated on the Master List.
Remedy Action:A corrected Master List for Panocell-20, lot 52872 is attached to this notification (See attached); it is identified with an "A" in the upper-left corner. Please replace your original Master List with this corrected Master List.
Athorized Representative/Importer/Distributor:Medical supplies & Services Co.Ltd Mediserv
Report Source:NCMDR
Source Ref. Number:84502E52661BA
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: IMMUCOR (Panocell-20).pdf