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U.S. Department of Health and Human Services

Class 2 Device Recall

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 Class 2 Device Recallsee related information
Date Initiated by FirmMay 28, 2004
Date PostedJuly 28, 2004
Recall Status1 Terminated 3 on September 10, 2004
Recall NumberZ-1229-04
Recall Event ID 29289
510(K)NumberK874485 
Product Classification Enzyme Immunoassay, Opiates - Product Code DJG
ProductTDx/TDxFLx Opiates Reagent, Product list number: 9673-60
Code Information Lot/Unit numbers Exp. date  10750Q100 9/22/04 09650Q100 9/15/04 
FEI Number 2623532
Recalling Firm/
Manufacturer		 Abbott Health Products, Inc.
Hwy 2 Km 58.0
Barceloneta PR 00617
For Additional Information ContactNydia I. Cancel
787-846-8256
Manufacturer Reason
for Recall		Abbott Diagnostics Division has found that the oxymorphone cross-reactivity information in the 'Specific Performance Characteristics' section of the TDx/TDxFLx Opiates Reagent package insert (commodity number 32-2087/R5) does not match the current product performance.
FDA Determined
Cause 2		Other
ActionA Device Correction Letter dated 5/28/04 was mailed to all customers. The letter explained the reason for the recall and provided specific instructions.
Quantity in Commerce941 kits
DistributionDistribution was to hospitals/laboratories
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 = DJG
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