FDA Device

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.

Hazard

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.

What You Should Do

Remedy

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.

Products

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
Brand
Diagnostica Stago, Inc.
UPC
Lot 0422671 exp. March 2006.

Units Affected

150 units