American Diagnostica, Inc. American Diagnostica Inc. ACTICLOT dPT Reference 824 in vitro diagnostic Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
American Diagnostica Inc. ACTICLOT dPT Reference 824 in vitro diagnostic
Brand
American Diagnostica, Inc.
Lot Codes / Batch Numbers
Lot Number: 061212, Exp 2008-12-22 Lot Number: 061020, Exp 2008-10-20
Products Sold
Lot Number: 061212 , Exp 2008-12-22 Lot Number: 061020, Exp 2008-10-20
American Diagnostica, Inc. is recalling American Diagnostica Inc. ACTICLOT dPT Reference 824 in vitro diagnostic due to Stability of product not assured. An increase of clotting time for both normal and abnormal plasmas. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Stability of product not assured. An increase of clotting time for both normal and abnormal plasmas
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026