Abbott Laboratories HPD/ADD/GPRD AxSYM Troponin-I Reagent Kit, list 3C29-20, 100 test kit; Abbott Laboratories, Abbott Park, IL 60064 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
AxSYM Troponin-I Reagent Kit, list 3C29-20, 100 test kit; Abbott Laboratories, Abbott Park, IL 60064
Brand
Abbott Laboratories HPD/ADD/GPRD
Lot Codes / Batch Numbers
lot numbers 10264M300, 10264M301, 10265M300, and 10265M301
Products Sold
lot numbers 10264M300, 10264M301, 10265M300, and 10265M301
Abbott Laboratories HPD/ADD/GPRD is recalling AxSYM Troponin-I Reagent Kit, list 3C29-20, 100 test kit; Abbott Laboratories, Abbott Park, IL 60064 due to An increase in complaints of higher than normal patient results, some from the healthy population range to above the diagnostic cutoff for an Acute My. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
An increase in complaints of higher than normal patient results, some from the healthy population range to above the diagnostic cutoff for an Acute Myocardial Infarction.
Recommended Action
Per FDA guidance
Recalled by telephone calls on 3/26/04 and a follow-up letter dated 3/25/04. The accounts were informed of the elevated patient results for the Troponin-I Reagent lots, and were requested to discontinue use and destroy any of the four affected lots found in inventory.
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