Recall Z-0408-06 ยท GGP Test, Qualitative And Quantitative Factor Deficiency
Diagnostica Stago, Inc.
STA Liatest Free Protein S, cat. 00516. These kits are intended for use with analyzers of the STA brand name for the quantitative determination of free protein S in plasma by the immuno-turbidimetric method.
| Date | Jan 20, 2006 (initiated Oct 26, 2005) |
| Status | Terminated |
| Reason | The mean levels (%) of normal and abnormal control plasmas (STA Liatest Control N and P) obtained with STA Liatest Free Protein S are found in the lower part of the range. |
| Root cause | Other |
| Action | Notification via recall letter was sent out on 10/26/2005. The letter was unsatisfactory and the letter was resent on 11/10/2005 as a recall letter. |
| Quantity | 150 units |
| Distribution | Product was distributed to 23 direct account customers nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.