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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 155 07 18 000
Date submitted: 7/31/2018
Manufacturer:Immucor GmbH.
Device Type:antigen typing for vial 4
Description:Reagent
Medical Device Identifier:Donor D2022 vial 4 of Panocell -10 , lot 22318
Reason of Field Safety Corrective Action:Immucor is issuing a product notification regarding the V antigen typing for donor D2022 vial 4 of Panocell -10 , lot 22318. Additional DNA testing of donor D2022 has confirmed the donor as V-, instead of V+ as indicated on the master list
Remedy Action:A corrected master list for Panocell-10 lot 22318 is attached to this notification , it is identified with an (A) in the upper-left corner. Please replace your original Master list with this corrected master list. An updated supplemental unconfirmed typing
Athorized Representative/Importer/Distributor:Medical supplies & Services Co.Ltd Mediserv
Report Source:NCMDR
Source Ref. Number:7A588009CE229
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: IMMUCOR.pdf