FDA Recall
Terminated
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 Manufactured by Agen Biomedical Ltd, Brisbane, QLD Australia.
Recall: Z-0594-2007
·
Initiated February 15, 2007
Recall
- Recall Number
- Z-0594-2007
- Event Number
- 37356
- Firm
- Inverness Medical Professional Diagnostics
- FEI Number
- 3003764480
- Product Code
- GHH
- Status
- Terminated
- Root Cause
- Other
- Initiated
- February 15, 2007
- Posted
- March 13, 2007
- Terminated
- May 8, 2007
- Address
- 2 Research Way, Princeton, NJ, 08540-6628
Description
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 Manufactured by Agen Biomedical Ltd, Brisbane, QLD Australia.
Reason
Lot PX018A is exhibiting a decrease in sensitivity affecting the qualitative result around the cut off.
Action
Recall notification letters were sent to all customers on 2/14/07 by first class mail.
Distribution
Worldwide, including USA, Puerto Rico, and Canada.
Quantity
382 kits