—#106792

Product

AU Clinical Chemistry Analyzers: Model Number: AU400 Clinical Chemistry Analyzer, AU400(e) Clinical Chemistry Analyzer, AU480 Clinical Chemistry Analyzer. The AU Clinical Chemistry Analyzers are fully automated photometric analyzers intended for clinical laboratory use. Applications include colorimetric, turbidimetric, latex agglutination, and homogeneous enzyme immunoassay.

FDA product code: JJE — Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Device class: Class 1
Medical specialty: Clinical Chemistry
510(k) numbers: K003721, K011720, K961274, K981743
Affected lot / code info: all serial numbers

Why it was recalled

The recall was initiated because Beckman has confirmed that the AU Clinical Chemistry Analyzers may experience cuvette overflow.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

Beckman Coulter sent an "UPDATE TO PCA -14563: URGENT PRODUCT CORRECTION" letter dated April 27, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter is a communication which describes an alternative approach to detecting cuvette overflow. Additionally, a response form was enclosed for customers to complete and return to the firm. Contact the Customer Support Center at (800) 854-3633 or on the Beckman Coulter website at www.beckmancoulter.com/customersupport/support/default.asp for questions regarding this notification.

Recalling firm

Firm: Beckman Coulter Inc.
Address: 250 S Kraemer Blvd, Brea, California 92821-6232

Distribution

Distribution pattern: Worldwide Distribution-including USA (nationwide).

Timeline

Recall initiated: 2010-07-12
Posted by FDA: 2012-02-07
Terminated: 2014-08-04
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #106792. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.