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 098 10 16 000
Date submitted:	10/13/2016

Manufacturer:	Abbott
Device Type:	ARCHITECT Lactic Acid
Description:	IVD
Medical Device Identifier:	List Number (LN): 9D89-21 Lot Numbers: 31497UN14, 09353UN15, 45216UN15, 14596UN15, 37055UN15, 14782UN16
Reason of Field Safety Corrective Action:	Abbott has identified negative interference from the drug N-Acetyl Cysteine (NAC) with the ARCHITECT Lactic Acid reagent (LN 9D89-21).
Remedy Action:	-Please review this letter with your Medical Director -Taking the above information into consideration, you may continue to use ARCHITECT Lactic Acid reagent (LN 9D89-21) -Please complete and return the Customer Reply Form -If you have forwarded the product listed above to other laboratories, please inform them of this Product Correction and provide to them a copy of this letter -Please retain this letter for your laboratory records
Athorized Representative/Importer/Distributor:	Medical supplies & Services Co.Ltd Mediserv
Report Source:	NCMDR
Source Ref. Number:	857811E6051F9
SFDA Comments:	SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:	Abbott.pdf

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