Recall Z-0594-2007
Inverness Medical Professional Diagnostics · initiated February 15, 2007
Product
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.
Codes / lots: Kit lot number: PX018A Test device batch number: 682-024 Catalog Number: 6100KVC Expiration date: 3/2008
Reason for recall
Lot PX018A is exhibiting a decrease in sensitivity affecting the qualitative result around the cut off.
FDA-determined cause: Other
Action taken
Recall notification letters were sent to all customers on 2/14/07 by first class mail.
Details
- Recall number
- Z-0594-2007
- Initiated
- February 15, 2007
- Posted by FDA
- March 13, 2007
- Terminated
- May 8, 2007
- Product code
- GHH – Fibrin Split Products
- Quantity
- 382 kits
- Distribution
- Worldwide, including USA, Puerto Rico, and Canada.
- Recalling firm
- Inverness Medical Professional Diagnostics, Princeton, NJ