RecallDepth

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.

Company
Diagnostica Stago, Inc.
Recall Initiated
October 26, 2005
Posted
January 20, 2006
Terminated
March 1, 2006
Recall Number
Z-0408-06
Quantity
150 units
Firm Location
Parsippany, NJ

Reason for Recall

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.

Distribution

Product was distributed to 23 direct account customers nationwide.

Lot / Code Info

Lot 0422671 exp. March 2006.

Root Cause

Other

Action Taken

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.

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