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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 080 04 14 000
Date submitted: 4/13/2014
Manufacturer:Abbott
Device Type:Reagent for Lipase
Description:IVD, SmartWash for Triglyceride, Lipase
Medical Device Identifier:Product : Lipase Reagent, List Number (LN) : 7D80

Lot numbers : 43827UQ12, 43994UQ07, 43819UQ03, 4596UQ08, 44449UQ05, 44775UQ09, 44127UQ06, 44930UQ11, 44334UQ07
Reason of Field Safety Corrective Action:The Lipase reagent package insert for the lots above has incorrect information regarding the required cuvette SmartWash for Triglyceride.
Remedy Action:- Verify that Lipase assay parameters (Assay: Lip, Number: 1029) on your ARCHITECT cSystems are configured for a Trig (Triglyceride) Cuvette SmartWash with 345 volume of 10% Detergent B per the table attached.

- If the Lipase SmartWash for Triglyceride is not configured, immediately update the Lipase SmartWash parameter by adding a Trig (Triglyceride) Cuvette SmartWash with 345 volume of 10% Detergent B per the table attached.

( Please see attached )
Athorized Representative/Importer/Distributor:Abbott Diagnostics Division, (012) 651-1077
Report Source:NCMDR
Source Ref. Number:D887EBEEFE436
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Abbott.pdf