Recall Z-1072-2007 ยท GGP Test, Qualitative And Quantitative Factor Deficiency
Diagnostica Stago, Inc.
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
| Date | Aug 9, 2007 (initiated May 8, 2007) |
| Status | Terminated |
| Reason | Specific lots of STA Liatest Free Protein S may result in low results in the assigned value ranges and sometimes outside the lower limit. |
| Root cause | Other |
| Action | Customers were sent a Product Recall Notification on May 8, 2007 by first class mail labeled " Recall notice, Open Immediately" |
| Quantity | 365 units |
| Distribution | Medical facilities nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K912468 | LIATEST PROTEIN S KIT American Bioproducts Co., Oct 2, 1991 |