| Class 2 Device Recall ARCHITECT i2000 |  |
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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = JJE
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