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Medical Devices Sector
قطاع الأجهزة الطبية
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
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