Recalls / —

—#38984

Product

Power Processor 3060 Tube Refrigerated Stockyard, P/N 6915556.

FDA product code

LXG — Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use

Device class

Class 1

Medical specialty

Clinical Chemistry

Affected lot / code info

Various.

Why it was recalled

Device does not maintain a uniform internal temperature within 2-8 C at warmer ambient temperatures.

Root cause (FDA determination)

Process change control

Action the firm took

Recall letters mailed 5/5/2005 request users monitor the temperature variances and evaluate for continued use in thier laboratory.

Recalling firm

Firm

Beckman Coulter Inc

Address

200 S Kraemer Blvd, Brea, California 92822-6208

Distribution

Distribution pattern

Nationwide and Canada

Timeline

Recall initiated

2005-05-05

Posted by FDA

2005-08-13

Terminated

2012-03-07

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #38984. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.