Z-0779-2007

American Diagnostica Inc. ACTICLOT dPT Reference 824 in vitro diagnostic

Name: Z-0779-2007 American Diagnostica Inc. ACTICLOT dPT Reference 824 in vitro diagnostic
Creator: American Diagnostica, Inc.
Published: 2007-02-28
License: https://open.fda.gov/license/

Sekisui Diagnostics, LLC / initiated 2007-02-28 / Terminated

FDA source

American Diagnostica, Inc. began a recall of American Diagnostica Inc. ACTICLOT dPT Reference 824 in vitro diagnostic on 2007-02-28. The reason FDA records is "Stability of product not assured. An increase of clotting time for both normal and abnormal plasmas". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0779-2007
Status: Terminated
Initiated: 2007-02-28
Posted: 2007-05-03
Terminated: 2016-07-06
Recalling firm: Sekisui Diagnostics, LLC
Product: American Diagnostica Inc. ACTICLOT dPT Reference 824 in vitro diagnostic
Product code: GIR Reagent, Russel Viper Venom
Reason for recall: Stability of product not assured. An increase of clotting time for both normal and abnormal plasmas
FDA 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 in commerce: 249 kits
Distribution: Worldwide, including USA, Canada, Germany, UK, Italy, Israel, Greece, and the Netherlands.
Product codes and lots: Lot Number: 061212 , Exp 2008-12-22 Lot Number: 061020, Exp 2008-10-20

Product code GIR

K052124Class IIActiclot, Model 824American Diagnostica, Inc. / cleared 2005-10-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)