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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
Diagnostica Stago, Inc.
Lot Codes / Batch Numbers
Lot 0422671 exp. March 2006.
Products Sold
Lot 0422671 exp. March 2006.
Diagnostica Stago, Inc. is recalling STA Liatest Free Protein S, cat. 00516. These kits are intended for use with analyzers of the STA b due to 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 low. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026