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Terminated

STA-R blood coagulation analyzer. Catalog Number 57160.

FDA Recall Z-1422-05 · Posted 2005-08-30

Recalling FirmDiagnostica Stago, Inc.
Recall StatusTerminated
Product CodeJPA
Date Initiated2005-06-20
Date Terminated2005-08-30
Product Quantity215 units

Reason for Recall

Concerning the STA-R blood coagulation analyzer, there is a possible failure mode associated with patient samples receiving prolonged exposure time to reagents during the cuvette roll change process.

Firm Action

Alert on the problem was sent out on 6/20/2005 to all customers alerting the problem and instructions on how to prevent the problem. The units are not be to returned.

Root Cause

Other

Distribution Pattern

Units were distributed to clinics and hospitals nationwide.

Official Source

View FDA Recall →

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

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