Recalls / —

—#117918

Product

AU2700 Clinical Chemistry Analyzer AU5400 Clinical Chemistry Analyzer Perform automated analysis of serum, urine, and other body fluids, including whole blood.

FDA product code

JJE — Analyzer, Chemistry (Photometric, Discrete), For Clinical Use

Device class

Class 1

Medical specialty

Clinical Chemistry

510(k) numbers

K003721, K011720

Affected lot / code info

All Serial Numbers  Model Numbers: AU2700, AU27000ISE, AU5421, AU5421ISE, AU5431.  Part Numbers: E0750053 N3663400  N3663700  N3664000  N3664200  N3664400  N3664600  N3664800  N3878500  1465600  64270G  E61DAU2700 N3663500  N3663600  N3663800  N3663900  N3664100  N3664300  N3664500  N3664700  N3664900  N3878600  O9102700 N3665000  N3665100  N3665200  N3665300  N3665400  N3878300  64542  A94504  N1683100  AU5431-U1  N3665500  N3665600  N3665700  N3665800  N3665900  N3878400

Why it was recalled

Beckman Coulter is recalling AU2700/AU2700 Plus & AU5400 Clinical Chemistry Analyzers becuase it was determined that the tubing/joint connections associated with these MODs may leak concentrated detergent. Beckman Coulter has received complaints that the joint connecting the tubing appears to disintegrate over time, causing a leak.

Root cause (FDA determination)

Component design/selection

Action the firm took

Beckman Coulter sent an Urgent Product Correction letter on April 26, 2013 along with a response form. The letter notified customers of the product, problem, and actions to be taken by the customers. Contact the Call Center at 800-854-3633 for questions regarding this notice.

Recalling firm

Firm

Beckman Coulter Inc.

Address

250 S Kraemer Blvd, Brea, California 92821-6232

Distribution

Distribution pattern

Worldwide Distribution-USA Nationwide and countries of: AU, CA, DE, ES, GB, IT, PT, and JP.

Timeline

Recall initiated

2013-04-26

Posted by FDA

2013-05-29

Terminated

2014-08-04

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #117918. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.