FDA Medical Device Recalls (openFDA)
American Diagnostica, Inc.: American Diagnostica Inc. ACTICLOT dPT Reference 824 in vitro diagnostic
- Recall number
- Z-0779-2007
- Recalling firm
- American Diagnostica, Inc.
- Product
- American Diagnostica Inc. ACTICLOT dPT Reference 824 in vitro diagnostic
- Status
- Terminated
- Initiated
- 2007-02-28
- Posted
- 2007-05-03
- Terminated
- 2016-07-06
- Reason
- Stability of product not assured. An increase of clotting time for both normal and abnormal plasmas
- Root cause
- Other
- Action
- American Diagnostica notified accounts by letter on 2/28/07 and 3/02/07 and international distributors on 2/28/07. Users are requested to discontinue use and destroy. Kits will be replaced.
- Quantity
- 249 kits
- Distribution
- Worldwide, including USA, Canada, Germany, UK, Italy, Israel, Greece, and the Netherlands.
- Lot, serial or model codes
- Lot Number: 061212 , Exp 2008-12-22 Lot Number: 061020, Exp 2008-10-20
- 510(k) numbers
- ["K052124"]
- PMA numbers
- not on file
- Product code
- GIR
- Firm FEI
- 1220602
- Firm city
- Stamford
- Firm state
- CT
- 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