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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 068 05 15 000
Date submitted: 5/14/2015
Manufacturer:Abbott
Device Type:Alkaline Wash
Description:Wash Solution for Chemistry Instrument
Medical Device Identifier:List Number (LN) : 9D31-20

Lot Number : 49059UN14

Expiration Date : 04-MAR-2016

UDI : N/A
Reason of Field Safety Corrective Action:Abbott Diagnostics is recalling Alkaline Wash lot number 49059UN14 due to leaking product and/or material received with loose bottle caps that may have leaked during shipment.
Remedy Action:1. Determine if you are using or have inventory of Alkaline Wash LN 9D31-20, lot number 49059UN14.

2. While wearing the appropriate Personal Protective Equipment (PPE), visually inspect your inventory. To ensure your safety, review the product Safety Data Sheet, available at www.abbottdiagnostics.com, or contact your local representative. For a detailed discussion of safety precautions, refer to the ARCHITECT System Operations Manual.
Athorized Representative/Importer/Distributor:Abbott Diagnostics Division
Report Source:NCMDR
Source Ref. Number:316F858C2D1DE
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Abbott.pdf