Reported Aug 14, 2013 · Terminated

Beckman Coulter AU5800 Clinical Chemistry Analyzer, All Serial Numbers. An automated chemistry analyzer that measures…

Beckman Coulter Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Beckman Coulter Inc. · 250 S Kraemer Blvd · Brea, CA · 92821-6232

Is this the product you have?

  • 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.
Lot codes and dates

20 of 20 products

Products covered by this recall
#Product as published
1Models, Catalogue Numbers: AU5811-01, A94906
2AU5811-02, A94907
3AU5811-03, A94908
4AU5811-04, A94909
5AU5811-06, A94910
6AU5821-01, A94911
7AU5821-02, A94912
8AU5821-03, A94913
9AU5821-04, A94914
10AU5821-06, A94915
11AU5831-01, A94916
12AU5831-02, A94917
13AU5831-03, A94918
14AU5831-04 A94919
15AU5831-06 A94920
16AU5831-01 A94921
17AU5831-02 A94922
18AU5831-03 A94923
19AU5831-04 A94924
20AU5831-06 A94925.
Amount recalled
338 units (11 units in the US)

Where it was sold

  • Nationwide
  • PR

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Oct 18, 2013 · Data as of Sep 19, 6:58 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.