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Terminated

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.

FDA Recall Z-0408-06 · Posted 2006-01-20

Recalling FirmDiagnostica Stago, Inc.
Recall StatusTerminated
Product CodeGGP
Date Initiated2005-10-26
Date Terminated2006-03-01
Product Quantity150 units

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.

Firm 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.

Root Cause

Other

Distribution Pattern

Product was distributed to 23 direct account customers nationwide.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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