Z-0977-2012

AU Clinical Chemistry Analyzers: Model Number: AU5400 Clinical Chemistry Analyzer. The AU Clinical Chemistry...

Name: Z-0977-2012 AU Clinical Chemistry Analyzers: Model Number: AU5400 Clinical Chemistry Analyzer. The AU Clinical Chemistry...
Creator: Beckman Coulter Inc.
Published: 2010-07-12
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2010-07-12 / Terminated

FDA source

Beckman Coulter Inc. began a recall of AU Clinical Chemistry Analyzers: Model Number: AU5400 Clinical Chemistry Analyzer. The AU Clinical Chemistry Analyzers are fully automated photometric... on 2010-07-12. The reason FDA records is "The recall was initiated because Beckman has confirmed that the AU Clinical Chemistry Analyzers may experience cuvette overflow". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0977-2012
Status: Terminated
Initiated: 2010-07-12
Posted: 2012-02-07
Terminated: 2014-08-04
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: AU Clinical Chemistry Analyzers: Model Number: AU5400 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.
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: The recall was initiated because Beckman has confirmed that the AU Clinical Chemistry Analyzers may experience cuvette overflow.
FDA root cause: Under Investigation by firm
Action: 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.
Quantity in commerce: 8225 units
Distribution: Worldwide Distribution-including USA (nationwide).
Product codes and lots: All analyzer serial numbers

Product code JJE

K011720Class IIOlympus Au5400 Clinical Chemistry AnalyzerOlympus America, Inc. / cleared 2001-06-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)