Z-1873-2013Class II

Beckman Coulter AU5800 Clinical Chemistry Analyzer, All Serial Numbers. An automated chemistry analyzer that...

Name: Z-1873-2013 Beckman Coulter AU5800 Clinical Chemistry Analyzer, All Serial Numbers. An automated chemistry analyzer that...
Creator: Beckman Coulter Inc.
Published: 2012-10-26
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2012-10-26 / Terminated / root cause: software

FDA source

Beckman Coulter Inc. began a recall of Beckman Coulter AU5800 Clinical Chemistry Analyzer, All Serial Numbers. An automated chemistry analyzer that measures analytes in samples, in combination with... on 2012-10-26. FDA classified it as Class II and gives the reason as "Beckman Coulter is recalling the AU8500 Clinical Chemistry Analyzer because there is no labeling on the diluted detergent tank to show the proper disposition of the on/off valve". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1873-2013
Classification: Class II
Status: Terminated
Initiated: 2012-10-26
Posted: 2013-08-02
Terminated: 2013-10-18
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Beckman Coulter AU5800 Clinical Chemistry Analyzer, All Serial Numbers. An automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC), material and other accessories.
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: Beckman Coulter is recalling the AU8500 Clinical Chemistry Analyzer because there is no labeling on the diluted detergent tank to show the proper disposition of the on/off valve.
Root cause tag: software
FDA root cause: Software design
Action: A recall notification letter was forwarded to all their customers on 11/1/12 who purchased the AU5800 Clinical Chemistry Analyzer. The customers were informed of the problems identified and the actions to be taken. Customers are instructed to complete and return the enclosed Reponse form within 10 days. Customers with questions are instructed to call (800) 854-3633 or contact their local BCI Representative.
Quantity in commerce: 338 units (11 units in the US)
Distribution: Worldwide Distribution-USA (nationwide) and Puerto Rico and the countries of Germany, China, Austria, Brazil, Italy, Argentina, Korea, Vietnam, Hungary, Ireland, France, Spain, Turkey, Switzerland, Israel, Australia, India, United Kingdom, Netherlands, Malaysia, Russian Federation, Japan, Taiwan, and Canada
Product codes and lots: Models, Catalogue Numbers: AU5811-01, A94906; AU5811-02, A94907; AU5811-03, A94908; AU5811-04, A94909; AU5811-06, A94910; AU5821-01, A94911; AU5821-02, A94912; AU5821-03, A94913; AU5821-04, A94914; AU5821-06, A94915; AU5831-01, A94916; AU5831-02, A94917; AU5831-03, A94918; AU5831-04 A94919; AU5831-06 A94920; AU5831-01 A94921; AU5831-02 A94922; AU5831-03 A94923; AU5831-04 A94924; AU5831-06 A94925.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1873-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1873-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-14	2013-08-02

Product code JJE

K112412Class IIAu5800(r) Chemistry AnalyzerBeckman Coulter, Inc. / cleared 2011-12-23

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)