Z-1834-2013Class II

AU5800 Clinical Chemistry Analyzer with Automation Ready Connection (All Software Versions), Model Numbers...

Name: Z-1834-2013 AU5800 Clinical Chemistry Analyzer with Automation Ready Connection (All Software Versions), Model Numbers...
Creator: Beckman Coulter Inc.
Published: 2013-06-03
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2013-06-03 / Terminated / root cause: software

FDA source

Beckman Coulter Inc. began a recall of AU5800 Clinical Chemistry Analyzer with Automation Ready Connection (All Software Versions), Model Numbers AU5811, AU5821, AU5831 and AU5841. This system is... on 2013-06-03. FDA classified it as Class II and gives the reason as "The recall was initiated because Beckman Coulter has identified a software error on AU5800 analyzers with the Automation Ready (AR) Sampler Kit. This software error results in the failure of the concentrated wash...". 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-1834-2013
Classification: Class II
Status: Terminated
Initiated: 2013-06-03
Posted: 2013-07-31
Terminated: 2014-08-23
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: AU5800 Clinical Chemistry Analyzer with Automation Ready Connection (All Software Versions), Model Numbers AU5811, AU5821, AU5831 and AU5841. This system is for in vitro diagnostic use only.
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: The recall was initiated because Beckman Coulter has identified a software error on AU5800 analyzers with the Automation Ready (AR) Sampler Kit. This software error results in the failure of the concentrated wash solution pump to stop, creating an overflow or leak on each analyzer unit.
Root cause tag: software
FDA root cause: Software design
Action: An Urgent Product Correction letter dated 5/29/13 was sent on the week of June 3, 2013 to all the customers who received the AU5800 Clinical Chemistry Analyzer with Automation Ready (AR) Connection (All Software versions). The letter informed the customers of the problem identified and the actions to be taken. Customers were instructed to complete and return the enclosed Response Form within 10 days and to share the information with their laboratory staff. Customers with questions are instructed to contact the 24 hours Call Center (Hotline) at (800) 854-3633 in the US and Canada.
Quantity in commerce: 76 units
Distribution: Worldwide Distribution, including Nationwide (US) and the countries of China, Italy, Japan, Canada, Turkey, United Kingdom, Singapore, Israel, and the Netherlands.
Product codes and lots: Model Numbers: AU5811-01, AU5821-01, AU5831-01, AU5841-01, AU5811-02, AU5821-02, AU5831-02, AU5841-02, AU5811-03, AU5821-03, AU5831-03, AU5841-03, AU5811-04, AU5821-04, AU5831-04, AU5841-04, AU5811-06, AU5821-06, AU5831-06, AU5841-06 Part Numbers: A94906, A94911, A94916, A91921 A94907, A94912, A94917, A94922 A94908, A94913, A94918, A94923 A94909, A94914, A91949, A94924 A94910, A94915, A94920, A94925 Serial Numbers: All

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1834-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1834-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-07	2013-07-31

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)