Z-2310-2016Class II

AU5800 Chemistry Analyzers, Reference No. A98352 The AU series are automated, clinical chemistry analyzers...

Name: Z-2310-2016 AU5800 Chemistry Analyzers, Reference No. A98352 The AU series are automated, clinical chemistry analyzers...
Creator: Beckman Coulter Inc.
Published: 2015-07-30
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2015-07-30 / Terminated / root cause: manufacturing process

FDA source

Beckman Coulter Inc. began a recall of AU5800 Chemistry Analyzers, Reference No. A98352 The AU series are automated, clinical chemistry analyzers that measure analytes in patient samples (serum... on 2015-07-30. FDA classified it as Class II and gives the reason as "Beckman coulter has received complaints regarding leaking and cracked C cups. When the cup cracks, coolant can leak onto the connectors of the Printed Circuit Boards (PCB) in the analyzer, resulting in a short-circuit...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2310-2016
Classification: Class II
Status: Terminated
Initiated: 2015-07-30
Posted: 2016-08-01
Terminated: 2017-02-15
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: AU5800 Chemistry Analyzers, Reference No. A98352 The AU series are automated, clinical chemistry analyzers that measure analytes in patient samples (serum, plasma, urine, CSF) in combination with appropriate reagents, calibrators, quality, control (QC) materials, and other accessories.
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: Beckman coulter has received complaints regarding leaking and cracked C cups. When the cup cracks, coolant can leak onto the connectors of the Printed Circuit Boards (PCB) in the analyzer, resulting in a short-circuit causing the instrument to go into a stop mode.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: In March 2011, the material and molding process of the Coolant cup (C cup) was changed. BEC did not issue a customer notification letter, as we do not believe that a notificationletter was either warranted or of any potential use or value to our customers, because the coolant cup (C cup) is an internal component that only a BEC Field Service Engineer (FSE) can access and inspect i.e., the C cup is not in a customer-accessible part of the analyzer. Thus, there are no specific actions the customer could take to inspect, identify, or mitigate the potential for a crack or leakage of the C cup. For questions regarding this recall call 714-961-4933.
Quantity in commerce: 2,130 units total (588 units in US)
Distribution: Worldwide Distribution - US (nationwide (including Guam and Puerto Rico), and Internationally to Albania, Algeria, Australia, Austria, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Botswana, Brazil, Bulgaria, Canada, China, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Eritrea, Ethiopia, Finland, France, Germany, Ghana, Gibraltar, Greece, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Kuwait, Lebanon, Liberia, Lithuania, Malawi, Malaysia, Mexico, Morocco, Mozambique, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nigeria, Norway, Oman, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Sierra Leone, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, United States Uruguay, Viet Nam, Zambia, Zimbabwe.
Product codes and lots: 1040016

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2310-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2308-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-10	2016-08-01
Z-2309-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-10	2016-08-01
Z-2310-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-10	2016-08-01

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)