CLASS II Device recall · Reported 13 Mar 2013 · FDA Enforcement Report

AU5800 Clinical Chemistry Analyzer recalled by Beckman Coulter

Beckman Coulter is recalling AU5800 Clinical Chemistry Analyzer, distributed nationwide in the US. The recall was initiated on 28 Nov 2012 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll serial numbers and all software versions 4.05 and prior. Part# Item# A94907 AU5811-02 A94912 AU5821-02 A94917 AU5831-02 A94922 AU5841-02 A94908 AU5811-03 A94913 AU5821-03 A94918 AU5831-03 A94923 AU5841-03 A94909 AU5811-04 A94914 AU5821-04 A94919 AU5831-04 A94924 AU5841-04 A94910 AU5811-06 A94915 AU5821-06 A94920 AU5831-06 A94925 AU5841-06

Quantity recalled28 in U.S.; 4 Canada; 318 to other foreign countries.

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0913-2013
FDA event ID: 64000
Recalling firm: Beckman Coulter, Brea, CA
Classification: Class II
Status: Terminated
Recall initiated: 28 Nov 2012
FDA classified: 6 Mar 2013
Reported: 13 Mar 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Insulin Pumps & Glucose Monitors

Timeline

28 Nov 2012	Recall initiated by company
6 Mar 2013	Classified by FDA	+98 days
13 Mar 2013	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Due to a software data storage limitation which only occurs under certain conditions, measurements of the Reagent Blank (RB) or Calibration (CAL) sample results are not saved and the software reverts to a previously stored, acceptable RB/CAL result.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Beckman Coulter AU5800 Clinical Chemistry Analyzer. An automated chemistry analyzer that measures analytes such as Glucose, Magnesium, and Potassium.

Where it was distributed

Worldwide Distribution-USA (nationwide) and the countries of Argentina, Australia, Austria, Brazil, China, Czech Republic, France, Germany, Hungary, India, Ireland, Israel, Italy, Korea Republic, Malaysia, Netherlands, Russian Federation, Spain, Switzerland, Taiwan, Turkey, United Kingdom, and Viet Nam.

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

All serial numbers and all software versions 4.05 and prior. Part# Item# A94907 AU5811-02 A94912 AU5821-02 A94917 AU5831-02 A94922 AU5841-02 A94908 AU5811-03 A94913 AU5821-03 A94918 AU5831-03 A94923 AU5841-03 A94909 AU5811-04 A94914 AU5821-04 A94919 AU5831-04 A94924 AU5841-04 A94910 AU5811-06 A94915 AU5821-06 A94920 AU5831-06 A94925 AU5841-06

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Beckman Coulter

All 334

Reported	Class	Recall	Company	Reason	Where
26 Aug 2026Device	CLASS II	DxC 500i Clinical Analyzer Modules using recalled by Beckman Coulter	Beckman Coulter	Packaging Defects	Nationwide
26 Aug 2026Device	CLASS II	DxC 500 AU Clinical Analyzer Modules using recalled by Beckman Coulter	Beckman Coulter	Packaging Defects	Nationwide
12 Aug 2026Device	CLASS II	REF # D23352, MicroScan LabPro V5.03 Panel Update 11 (US) recalled	Beckman Coulter	Other	Nationwide
12 Aug 2026Device	CLASS II	REF # D23354, MicroScan LabPro V5.03 Panel Update 11 DVD Kit (US) recalled	Beckman Coulter	Other	Nationwide
29 Apr 2026Device	CLASS II	Access Total T4 Calibrator recalled by Beckman Coulter	Beckman Coulter	Other	Nationwide

Other Insulin Pumps & Glucose Monitors recalls

All 459

Reported	Class	Recall	Company	Reason	Where
26 Aug 2026Device	CLASS II	MiniMed Insulin Pump recalled by Medtronic MiniMed	Medtronic MiniMed	Other	CA
26 Aug 2026Device	CLASS II	MiniMed Insulin Pump recalled by Medtronic MiniMed	Medtronic MiniMed	Other	CA
26 Aug 2026Device	CLASS II	MiniMed Insulin Pump recalled by Medtronic MiniMed	Medtronic MiniMed	Other	CA
15 Jul 2026Device	CLASS II	MiniMed Insulin Pump recalled by Medtronic MiniMed	Medtronic MiniMed	Device Malfunction	CA
8 Jul 2026Device	CLASS I	Omnipod (Eros) Pod recalled by Insulet	Insulet	Packaging Defects	Nationwide