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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NCMDR Recall

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Reference Number:	mdprc 123 07 18 000
Date submitted:	7/24/2018

Manufacturer:	Abbott
Device Type:	Alinity c Creatine Kinase
Description:	Instrument
Medical Device Identifier:	List Number : 08P4220 Lot Number : 99634UN18 UDI Number : (01)00380740132590 (17)190102(10)99634UN18
Reason of Field Safety Corrective Action:	The purpose of this letter is to inform you of a product recall for the Alinity c Creatine Kinase (CK) reagent lot number listed above and to provide instructions on what actions your laboratory must take. Abbott has identified a product stability issue that may lead to the following: Message code 1041 “Unable to calculate result. Reaction check failure.” Quality Control (QC) results out of range low
Remedy Action:	If you have an alternate reagent lot available in inventory THEN Immediately discontinue use of the reagent lot number listed above and switch to the alternate reagent lot. Destroy any remaining inventory of impacted material according to your laboratory .
Athorized Representative/Importer/Distributor:	Medical supplies & Services Co.Ltd Mediserv
Report Source:	NCMDR
Source Ref. Number:	810519B1F4244
SFDA Comments:	SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:	Abbott.pdf

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