Beckman Coulter Inc.: Medical Device Recall in 2013 - (Recall #: Z-1873-2013)

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, 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 Classification:

Class II

Date Initiated: October 26, 2012

Date Posted: August 14, 2013

Recall Number: Z-1873-2013

Event ID: 63605

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.

Status: Terminated

Product Quantity: 338 units (11 units in the US)

Code Information:

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.

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated