Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1369-05

Power Processor 3060 Tube Refrigerated Stockyard, P/N 6915556

Siemens Healthcare Diagnostics Inc. / initiated 2005-05-05 / Terminated

Beckman Coulter Inc began a recall of Power Processor 3060 Tube Refrigerated Stockyard, P/N 6915556 on . The reason FDA records is "Device does not maintain a uniform internal temperature within 2-8 C at warmer ambient temperatures". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-1369-05
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Siemens Healthcare Diagnostics Inc.
Product
Power Processor 3060 Tube Refrigerated Stockyard, P/N 6915556.
Product code
LXG Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
Reason for recall
Device does not maintain a uniform internal temperature within 2-8 C at warmer ambient temperatures.
FDA root cause
Process change control
Action
Recall letters mailed 5/5/2005 request users monitor the temperature variances and evaluate for continued use in thier laboratory.
Quantity in commerce
46
Distribution
Nationwide and Canada
Product codes and lots
Various.