Diagnostica Stago, Inc. STA-R blood coagulation analyzer. Catalog Number 57160. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
STA-R blood coagulation analyzer. Catalog Number 57160.
Brand
Diagnostica Stago, Inc.
Lot Codes / Batch Numbers
All units distributed under Catalog Number 57160.
Products Sold
All units distributed under Catalog Number 57160.
Diagnostica Stago, Inc. is recalling STA-R blood coagulation analyzer. Catalog Number 57160. due to Concerning the STA-R blood coagulation analyzer, there is a possible failure mode associated with patient samples receiving prolonged exposure time to. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026