AU5800 Chemistry Analyzer

• • Terminated Z-1704-2017 FDA Class II ·initiated 13 Feb 2017 ·on shared 510(k) K112412

  Beckman Coulter is recalling the Rack ID Labels because the Rack ID number displayed and the Rack ID barcode label do not match.

• • Terminated Z-2310-2016 FDA Class II ·initiated 30 Jul 2015 ·on shared 510(k) K112412

  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.

• • Terminated Z-0153-2014 FDA Class II ·initiated 9 Sep 2013 ·on shared 510(k) K112412

  The recall was initiated because Beckman Coulter has confirmed that some AU Clinical Chemistry Analyzer ISE units can experience premature ISE REF (Reference) valve failure. Premature valve failure can be detected by the presence of air bubbles in the ISE REF solution tubing on the ISE unit. If air bubbles are present, accuracy of the ISE test results may be affected.

• • Terminated Z-1834-2013 FDA Class II ·initiated 3 Jun 2013 ·on shared 510(k) K112412

  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.

• • Terminated Z-1167-2013 FDA Class II ·initiated 20 Mar 2013 ·on shared 510(k) K112412

  Beckman Coulter, Inc. initiated this recall because there is a software error that has the potential to cause the reporting of erroneous patient results because of misidentification by the AU5800 system.

• • Terminated Z-0913-2013 FDA Class II ·initiated 28 Nov 2012 ·on shared 510(k) K112412

  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.

• • Terminated Z-1873-2013 FDA Class II ·initiated 26 Oct 2012 ·on shared 510(k) K112412

  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.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Full name

AU5800(R) Chemistry Analyzer

510(k) Number

K112412 ↗

FDA Product Code

CEM

Device Class

Class II

Regulation

21 CFR Part 862.1600

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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See all devices from Beckman Coulter, Inc. →

• What types of biochemical tests can the AU5800 Chemistry Analyzer perform, and how does it measure them?

  The AU5800 Chemistry Analyzer performs both photometric and ion-selective electrode (ISE) assays to measure a wide range of biochemical parameters, including electrolytes, enzymes, and lipids. Photometric assays detect light absorption changes in reactions, while ISE tests directly measure ion concentrations like potassium, enabling precise quantitative analysis of patient samples for routine and specialized clinical chemistry testing.

• Is the AU5800 Chemistry Analyzer designed for single-use or repeated use in a clinical setting?

  The AU5800 Chemistry Analyzer is a reusable instrument, not intended for single-use. It is supplied as a non-sterile device and is meant to be used repeatedly in clinical laboratories for high-throughput biochemical analysis, supporting up to 1800 photometric and 600 ISE tests per hour.

• What is the throughput capacity of the AU5800 Chemistry Analyzer, and how does this benefit clinical workflows?

  The AU5800 Chemistry Analyzer is engineered for high throughput, processing up to 1800 photometric tests and 600 ion-selective electrode (ISE) tests per hour. This capacity helps laboratories efficiently handle large volumes of patient samples, reducing turnaround time and improving workflow efficiency for routine and specialized biochemical testing.

• What regulatory pathways has the AU5800 Chemistry Analyzer followed, and what does this mean for its use in clinical laboratories?

  The AU5800 Chemistry Analyzer has received FDA 510(k) clearance and IVDR (In Vitro Diagnostic Regulation) conformity, confirming its compliance with U.S. and EU regulatory standards for clinical chemistry analyzers. This means it is authorized for use in clinical laboratories in both markets, adhering to stringent requirements for accuracy, safety, and performance in biochemical testing.

• Does the AU5800 Chemistry Analyzer include built-in quality control features, and how might this impact laboratory operations?

  Yes, the AU5800 Chemistry Analyzer includes integrated quality control functions, which help ensure the reliability and accuracy of test results. These features allow laboratories to monitor performance continuously, reducing the risk of errors and ensuring consistent, high-quality biochemical analysis for patient samples.