AxSYM Troponin-I Reagent Kit, list 3C29-20, 100 test kit; Abbott Laboratories, Abbott Park, IL 60064
This recall has been terminated (originally issued July 20, 2004).
- Company
- Abbott Laboratories Hpd/Add/Gprd
- Recall Initiated
- March 26, 2004
- Posted
- July 20, 2004
- Terminated
- October 14, 2004
- Recall Number
- Z-0782-04
- Quantity
- 7,394 kits
- Firm Location
- Abbott Park, IL
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
Nationwide and internationally to Abbott affiliates in Argentina, Canada, Germany, Singapore, Hong Kong, Taiwan, Australia, New Zealand, Thailand, China and Korea.
Lot / Code Info
lot numbers 10264M300, 10264M301, 10265M300, and 10265M301
Root Cause
Other
Action Taken
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.