RecallDepth

STA-R blood coagulation analyzer. Catalog Number 57160.

Company
Diagnostica Stago, Inc.
Recall Initiated
June 20, 2005
Posted
August 30, 2005
Terminated
August 30, 2005
Recall Number
Z-1422-05
Quantity
215 units
Firm Location
Parsippany, NJ

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.

Distribution

Units were distributed to clinics and hospitals nationwide.

Lot / Code Info

All units distributed under Catalog Number 57160.

Root Cause

Other

Action Taken

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.

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