FDA Device

STA-R blood coagulation analyzer. Catalog Number 57160.

Hazard

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.

What You Should Do

Remedy

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.

Products

STA-R blood coagulation analyzer. Catalog Number 57160.
Brand
Diagnostica Stago, Inc.
UPC
All units distributed under Catalog Number 57160.

Units Affected

215 units