Recall Z-0594-2007 ยท GHH Fibrin Split Products
Inverness Medical Professional Diagnostics
Clearview Simplify D-dimer, in vitro diagnostic for qualitative detection of D-dimer in human whole blood and plasma. Product No. 61100KVC 10 test devices containing anti D-dimer monoclonal antibody and sheep anti-mouse antibody 1 x 2.6 mL buffer containing 0.9% sodium chloride and 0.05% sodium azide 10 plastic pipettes Wampole Laboratories Inverness Medical Professional diagnostics group Manuf
| Date | Mar 13, 2007 (initiated Feb 15, 2007) |
| Status | Terminated |
| Reason | Lot PX018A is exhibiting a decrease in sensitivity affecting the qualitative result around the cut off. |
| Root cause | Other |
| Action | Recall notification letters were sent to all customers on 2/14/07 by first class mail. |
| Quantity | 382 kits |
| Distribution | Worldwide, including USA, Puerto Rico, and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K993276 | SIMPLIFY D-DIMER, MODEL DCGK1 Agen Biomedical , Ltd., Dec 14, 1999 |