FDA Medical Device Recalls (openFDA)
Abbott Laboratories HPD/ADD/GPRD: AxSYM Troponin-I Reagent Kit, list 3C29-20, 100 test kit; Abbott Laboratories, Abbott Park, IL 60064
- Recall number
- Z-0782-04
- Recalling firm
- Abbott Laboratories HPD/ADD/GPRD
- Product
- AxSYM Troponin-I Reagent Kit, list 3C29-20, 100 test kit; Abbott Laboratories, Abbott Park, IL 60064
- Status
- Terminated
- Initiated
- 2004-03-26
- Posted
- 2004-07-20
- Terminated
- 2004-10-14
- Reason
- 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.
- Root cause
- Other
- Action
- 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.
- Quantity
- 7,394 kits
- Distribution
- Nationwide and internationally to Abbott affiliates in Argentina, Canada, Germany, Singapore, Hong Kong, Taiwan, Australia, New Zealand, Thailand, China and Korea.
- Lot, serial or model codes
- lot numbers 10264M300, 10264M301, 10265M300, and 10265M301
- 510(k) numbers
- ["K974103"]
- PMA numbers
- not on file
- Product code
- MMI
- Firm FEI
- 1415939
- Firm city
- Abbott Park
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28