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Terminated

STA Compact and STA Compact CT, Haemostasis Analyzer, in vitro diagnostic.

FDA Recall Z-0039-2008 · Posted 2007-10-11

Recalling FirmDiagnostica Stago, Inc.
Recall StatusTerminated
Product CodeGKP
Date Initiated2007-07-30
Date Terminated2007-12-17
Product Quantity41 units installed

Reason for Recall

Incorrect results. Internal investigation determined the presence of a defective measurement head which can impact the results of clotting tests by either yielding no result or rendering an error message.

Firm Action

Recall notification letters were mailed to consignees on 7/30/07 by first class mail.

Root Cause

Process design

Distribution Pattern

Nationwide.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K961579STA COMPACT AUTOMATED MULTI-PARAMETRIC ANALYZERAmerican Bioproducts Co. · 1996-07-10

Official Source

View FDA Recall →

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

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