SFDA National Center for Medical Devices Reporting

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Medical Devices Sector قطاع الأجهزة الطبية	NCMDR National Center for Medical Devices Reporting المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
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NCAR Recall

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Reference Number:	mdprc 001 05 11 000
Date submitted:	5/1/2011

Manufacturer:	DiaMed AG
Device Type:	Blood grouping system, automated
Description:	An automated blood screening system.
Medical Device Identifier:	IH-1000 analyzer in combination with ID-DiaClon Anti-D.
Reason of Field Safety Corrective Action:	The manufacturer has observed that test profiles on the IH-1000 analyzer, when ID-DiaClon Anti-D is included, may generate incoherent results in the group of tests contained in the profile.
Remedy Action:	The manufacturer advises that test profiles run on IH-1000 analyzers could be affected when the reagent ID-DiaClon Anti-D is used. Further investigations are ongoing at the manufacturer. As a protective measure the manufacturer has informed affiliates and customers to immediately stop using ID-DiaClon Anti-D in combination with the IH-1000 analyzer and the following test codes: PR09X (Antigen: Anti-D for Dweak confirmation, IAT, 5053) and PR09H (Antigen: Anti-D for Dweak confirmation, 5054).
Athorized Representative/Importer/Distributor:	Al Nahir Trading Co, Riaydh, (01) 4770444
Report Source:	http://www.sfda.gov.sa/En/MedicalEquipments/recalls/NCAR+Brief.htm
Source Ref. Number:	CH-2011-04-27-016
SFDA Comments:	SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:	No Attachments

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