Abbott Health Products, Inc. TDx/TDxFLx Opiates Reagent, Product list number: 9673-60 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
TDx/TDxFLx Opiates Reagent, Product list number: 9673-60
Brand
Abbott Health Products, Inc.
Lot Codes / Batch Numbers
Lot/Unit numbers Exp. date 10750Q100 9/22/04 09650Q100 9/15/04
Products Sold
Lot/Unit numbers Exp. date 10750Q100 9/22/04 09650Q100 9/15/04
Abbott Health Products, Inc. is recalling TDx/TDxFLx Opiates Reagent, Product list number: 9673-60 due to Abbott Diagnostics Division has found that the oxymorphone cross-reactivity information in the 'Specific Performance Characteristics' section of the T. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
A Device Correction Letter dated 5/28/04 was mailed to all customers. The letter explained the reason for the recall and provided specific instructions.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026