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U.S. Department of Health and Human Services

Class 2 Device Recall ARCHITECT i2000SR System

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  Class 2 Device Recall ARCHITECT i2000SR System see related information
Date Initiated by Firm September 09, 2015
Create Date October 26, 2015
Recall Status1 Terminated 3 on November 17, 2016
Recall Number Z-0163-2016
Recall Event ID 72154
510(K)Number K980367  
Product Classification Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
Product ARCHITECT i2000SR System
The Abbott ARCHITECT System is intended for In Vitro diagnostic use only. The ARCHITECT system is designed to perform automated immunoassay tests, utilizing CMIA (chemiluminescent microparticle assay) detection technology.
Code Information ISR03967, ISR04737, ISR01461, ISR01998, ISR01964, ISR02446, ISR02751, ISR02781, ISR05266, ISR04520, ISR01460, ISR01442, ISR01988, ISR03034, ISR01194, ISR01583, ISR01955, ISR02437, ISR03144, ISR03352, ISR04369, ISR02360, ISR02361, ISR02842, ISR03495, ISR03756, ISR04244, ISR04420, ISR05155, ISR05240, ISR05242, ISR05433, ISR05671, ISR05883, ISR05946, ISR06050, ISR06054, ISR06837, ISR06864, ISR01696, ISR02073, ISR02264, ISR02269, ISR02999, ISR03668, ISR03901, ISR04053, ISR04165, ISR04388, ISR04586, ISR04619, ISR04770, ISR04773, ISR04775, ISR04801, ISR04996, ISR05202, ISR05662, ISR05732, ISR05751, ISR06406, ISR06592, ISR07108, ISR07240, ISR07741
Recalling Firm/
Manufacturer		 Abbott Laboratories, Inc
1921 Hurd Dr
Irving TX 75038-4313
For Additional Information Contact Customer Service
877-422-2688
Manufacturer Reason
for Recall		 Incorrect tubing.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Abbott Laboratories executed a Technical Service Bulletin on August 14, 2015.. The firm sent out a Product Correction notice on September 9, 2015 to all affected customers. The notice identified the product, the problem, and the action to be taken by the customer. Customers were instructed that an Abbott representative will make all necessary arrangements for replacing tubing on the impacted instruments. Customers were asked to retain a copy of the notice for their records. Customers with questions were instructed to contact Customer Service at 1-877-4ABBOTT. Customers outside the US should contact their local area Customer Service. For questions regarding this recall call 877-422-2688.
Quantity in Commerce 65 units
Distribution Worldwide Distribution - US (nationwide) and Internationally to France, Netherlands, Greece, Italy, Belgium, India, Austria, Germany, and Japan
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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