Recall Z-1072-2007
Diagnostica Stago, Inc. · initiated May 8, 2007
Product
STA Liatest Free Protein S For in vitro diagnostic use. 2-8 degrees C Distributed in the USA by: Diagnostica Stago, Inc. 5 Century Drive Parsippany, NJ Phone 800-abc coag 1 - 6 x 5 ml Buffer 2 - 6 x 6 ml Latex
Codes / lots: Catalog number: 0516 Lot Numbers: 061312, Exp 5/31/07; 061991, Exp 8/31/07; 062633, Exp 10/31/07; 063281, Exp 12/31/07
Reason for recall
Specific lots of STA Liatest Free Protein S may result in low results in the assigned value ranges and sometimes outside the lower limit.
FDA-determined cause: Other
Action taken
Customers were sent a Product Recall Notification on May 8, 2007 by first class mail labeled " Recall notice, Open Immediately"
Details
- Recall number
- Z-1072-2007
- Initiated
- May 8, 2007
- Posted by FDA
- August 9, 2007
- Terminated
- October 13, 2010
- Product code
- GGP – Test, Qualitative And Quantitative Factor Deficiency
- Quantity
- 365 units
- Distribution
- Medical facilities nationwide
- Recalling firm
- Diagnostica Stago, Inc., Parsippany, NJ