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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 008 07 17 001
Date submitted:	12/12/2017

Manufacturer:	Abbott Laboratories Inc
Device Type:	ARCHITECT c4000 Cuvette Segment
Description:	Analyzers, Laboratory, Clinical Chemistry/Immunoassay
Medical Device Identifier:	List Number (LN): 02P75‐01 .................................................... NCMDR Update code : Product Name : ( List Number ) - ARCHITECT c8000 Cuvette Segment : ( 01G46‐01 ) - ARCHITECT c16000 Cuvette Segment : ( 09D32‐05 )
Reason of Field Safety Corrective Action:	The ARCHITECT c4000 Cuvette Segment may detach from the bottom of the segment. When a cuvette segment is detached, cuvettes may be seated lower than the designed height.
Remedy Action:	1) Please contact your Abbott representative to schedule an inspection of your cuvette segments. 2) If a detached segment is identified: -A replacement segment will be provided at no charge. -Follow your laboratory protocol regarding previously reported patient results from cuvettes within the impacted segment ----------------------------------- NCMDR Update Action : Abbott recommends the customer adhere to the new instructions listed in Appendix A to avoid damaging the cuvette segments. The procedures listed in Appendix A (See attached FSN) provide additional guidance for operators to avoid damaging the cuvette segments. The procedures will be updated in a future version of the ARCHITECT Operations Manual. If a cuvette segment with a detached bottom is identified, replace it before performing any additional testing on your ARCHITECT Clinical Chemistry System.
Athorized Representative/Importer/Distributor:	Medical supplies & Services Co.Ltd Mediserv
Report Source:	NCMDR
Source Ref. Number:	69A899B3B9316 , 0456B648521AA
SFDA Comments:	SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:	Abbott Laboratories.pdf

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