Recall Z-0779-2007 ยท GIR Reagent, Russel Viper Venom
American Diagnostica, Inc.
American Diagnostica Inc. ACTICLOT dPT Reference 824 in vitro diagnostic
| Date | May 3, 2007 (initiated Feb 28, 2007) |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K052124 | ACTICLOT, MODEL 824 American Diagnostica, Inc., Oct 17, 2005 |