Beckman Coulter Inc.: Medical Device Recall in 2013 - (Recall #: Z-0913-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: November 28, 2012

Date Posted: March 13, 2013

Recall Number: Z-0913-2013

Event ID: 64000

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.

Status: Terminated

Product Quantity: 28 in U.S.; 4 Canada; 318 to other foreign countries.

Code Information:

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

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated