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Terminated

STA Liatest Free Protein S For in vitro diagnostic use. 2-8 degrees C Distributed in the USA by: Diagnostica Stago, Inc. 5 Century Drive Parsippany, NJ Phone 800-abc coag 1 - 6 x 5 ml Buffer 2 - 6 x 6 ml Latex

FDA Recall Z-1072-2007 · Posted 2007-08-09

Recalling FirmDiagnostica Stago, Inc.
Recall StatusTerminated
Product CodeGGP
Date Initiated2007-05-08
Date Terminated2010-10-13
Product Quantity365 units

Reason for Recall

Specific lots of STA Liatest Free Protein S may result in low results in the assigned value ranges and sometimes outside the lower limit.

Firm Action

Customers were sent a Product Recall Notification on May 8, 2007 by first class mail labeled " Recall notice, Open Immediately"

Root Cause

Other

Distribution Pattern

Medical facilities nationwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K912468LIATEST PROTEIN S KITAmerican Bioproducts Co. · 1991-10-02

Official Source

View FDA Recall →

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

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