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U.S. Department of Health and Human Services

Class 2 Device Recall ARCHITECT i2000

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  Class 2 Device Recall ARCHITECT i2000 see related information
Date Initiated by Firm December 12, 2006
Date Posted February 07, 2007
Recall Status1 Terminated 3 on September 24, 2007
Recall Number Z-0415-2007
Recall Event ID 36996
510(K)Number K983212  
Product Classification in vitro diagnostic - Product Code JJE
Product ARCHITECT i2000 Processing Module, for in vitro diagnostics, List Number 08C89-01; Temperature Controller Board Part #78560-109; distributed by Abbott Laboratories, Irving, TX.
Code Information Serial numbers: 1202790, 1202804, 1202805, 1202806, 1202807, 1202808, 1202809, 1202810, 1202811, 1202812, 1202813, 1202814, 1202815, 1202816, 1202817, 1202818, 1202819, 1202820, 1202821, 1202822, 1202823, 1202824, 1202825, 1202826, 1202827, 1202828, 1202829, 1202830, 1202831, 1202832, 1202833, 1202834, 1202835, 1202836, 1202837, 1202838, 1202839, 1202840, 1202841, 1202842, 1202843, 1202844, 1202845, 1202846, 1202847, 1202848, 1202849, 1202850, 1202851, 1202852, 1202853, 1202854, 1202855, 1202856, 1202857, 1202858, 1202859.
Recalling Firm/
Manufacturer		 Abbott Laboratories, Inc
1921 Hurd Drive
PO Box 152020
Irving TX 75038
Manufacturer Reason
for Recall		 The re-designed ARCHITECT Temperature Controller Board has been identified as being susceptible to electromagnetic interference (EMI) in the laboratory. This can cause a board reset condition, stopping temperature control function of the board. Situation does not stop analyzer operation and does not generate an error condition alerting operator when condition occurs.
FDA Determined
Cause 2		 Other
Action Firm contacted consignees by telephone and fax with instructions to verify proper functioning of the Temperature Controller Board starting December 13, 2006.
Quantity in Commerce 57 units.
Distribution Worldwide, including USA, Argentina, Australia, Brazil, Canada, Chile, Columbia, Dominican Republic, Germany, Hong Kong, Jamaica, Japan, Korea, Mexico, New Zealand, Peru, Puerto Rico, Singapore, Taiwan, Thailand, Trinidad, Tobago, Uruguay, and Venezuela.
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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