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U.S. Department of Health and Human Services

Class 2 Device Recall Architect c8000

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  Class 2 Device Recall Architect c8000 see related information
Date Initiated by Firm June 11, 2015
Date Posted July 22, 2015
Recall Status1 Terminated 3 on February 09, 2016
Recall Number Z-2202-2015
Recall Event ID 71473
510(K)Number K980367  
Product Classification Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
Product ARCHITECT c8000 System List Number 01G06-98

Product Usage: The Abbott ARCHITECT cSystem is intended for In Vitro diagnostic use only. It is designed to perform automated: chemistry tests, utilizing photometry and potentiometric technology.
Code Information Serial Numbers: C802239, C802312, C802260, C802447, C801911
Recalling Firm/
Manufacturer		 Abbott Laboratories
100 Abbott Park Rd
Abbott Park IL 60064-3502
Manufacturer Reason
for Recall		 The ARCHITECT c8000 instrument contains tubing that does not meet specifications and has the potential to leak.
FDA Determined
Cause 2		 Mixed-up of materials/components
Action Abbott notified thier affected consignees via phone or visit on 5/29/15. A follow up Product Recall notification letter dated June 4, 2015 was sent to affected customers. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to immediately discontinue use of the product, Abbott representative will be make all necessary arrangements for replacing your impacted instruments(s), follow your laboratory protocol regarding the need to review previously reported patient results and retain this notification for laboratory records. For questions contact Customer Service at 1-877-4ABBOTT.
Quantity in Commerce 5 units
Distribution US Nationwide Distribution in the states of CA, AL, NY and WI.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = JJE and Original Applicant = ABBOTT LABORATORIES
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