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U.S. Department of Health and Human Services

Class 2 Device Recall Architect FSH Calibrators

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 Class 2 Device Recall Architect FSH Calibratorssee related information
Date Initiated by FirmSeptember 07, 2006
Date PostedOctober 12, 2006
Recall Status1 Terminated 3 on September 09, 2011
Recall NumberZ-0025-2007
Recall Event ID 36405
510(K)NumberK032458 
Product Classification FSH in vitro diagnostic - Product Code JIT
ProductArchitect FSH Calibrators (LN 6C24-01), for in vitro diagnostic use.
Code Information Lot # 33363Q100 Expiration Date 11/04/2006
Recalling Firm/
Manufacturer		 Abbott Diagnostic International, Ltd.
Carr 2 Km 58.0
Cruce Davila
Barceloneta PR 00617-3009
Manufacturer Reason
for Recall		Following a customer complaint, Abbott found an atypical stability profile for the lot of the calibrators listed in this recall. The investigation to date has shown that both controls and patient results have shifted upwards over time together.
FDA Determined
Cause 2		Other
ActionThe Device Recall Letter dated September 07, 2006, and Customer Reply Form was sent via Federal Express Priority mail to all customers who received the affected lots.
Quantity in Commerce624
DistributionWorldwide, including USA, Puerto Rico, Canada, Mexico, Guatemala, Costa Rica, Venezuela, Colombia, Ecuador, Chile, Uruguay, Argentina, Brazil, Dominican Republic, El Salvador, Germany, Japan, Singapore, Hong Kong, Taiwan, Thailand, South Korea, Australia, Honduras, Trinidad-Tobago, St. Vincent, Bahamas, Panama, and Cayman Islands.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = JIT
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