FDA Medical Device Recalls (openFDA)
Abbott Laboratories MPG: ARCHITECT STAT Troponin-I Reagent Kit, list 2K41-20; each 400 test kit contains 4 bottles each of microparticles, conjugate and assay diluent; Abbott Laboratories, Abbott Park, IL 60064
- Recall number
- Z-0513-06
- Recalling firm
- Abbott Laboratories MPG
- Product
- ARCHITECT STAT Troponin-I Reagent Kit, list 2K41-20; each 400 test kit contains 4 bottles each of microparticles, conjugate and assay diluent; Abbott Laboratories, Abbott Park, IL 60064
- Status
- Terminated
- Initiated
- 2005-12-21
- Posted
- 2006-02-14
- Terminated
- 2006-07-31
- Reason
- There has been an increase in customer complaints observed for failure to calibrate or inability to generate patient result errors.
- Root cause
- Other
- Action
- Abbott sent recall letters dated 12/20/05 to the laboratory accounts via Federal Express Priority on 12/21/05. The accounts were informed of the increase in customer complaints for failure to calibrate or inability to generate patient result errors for the Troponin-I Reagent lot, and were requested to discontinue use and destroy any of the affected lot found in inventory for replacement.
- Quantity
- 181 kits
- Distribution
- Nationwide and internationally to Canada, Australia, Germany and Taiwan
- Lot, serial or model codes
- list 2K41-20, lot 95567G005, exp 6-30-2006
- 510(k) numbers
- ["K041192"]
- 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