CLASS II Device recall · Reported 5 Jun 2013 · FDA Enforcement Report
AU2700 Clinical Chemistry Analyzer AU5400 Clinical recalled
Beckman Coulter is recalling AU2700 Clinical Chemistry Analyzer AU5400 Clinical Chemistry Analyzer Perform automated, distributed nationwide in the US. The recall was initiated on 26 Apr 2013 and the FDA has classified it as Class II.
Check your package
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-1430-2013
- FDA event ID
- 65118
- Recalling firm
- Beckman Coulter, Brea, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 26 Apr 2013
- FDA classified
- 29 May 2013
- Reported
- 5 Jun 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Test Kits & Diagnostics
Timeline
| 26 Apr 2013 | Recall initiated by company | |
| 29 May 2013 | Classified by FDA | +33 days |
| 5 Jun 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
Beckman Coulter is recalling AU2700/AU2700 Plus & AU5400 Clinical Chemistry Analyzers becuase it was determined that the tubing/joint connections associated with these MODs may leak concentrated detergent. Beckman Coulter has received complaints that the joint connecting the tubing appears to disintegrate over time, causing a leak.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
AU2700 Clinical Chemistry Analyzer AU5400 Clinical Chemistry Analyzer Perform automated analysis of serum, urine, and other body fluids, including whole blood.
Where it was distributed
Worldwide Distribution-USA Nationwide and countries of: AU, CA, DE, ES, GB, IT, PT, and JP.
Questions about this recall
Why was it recalled?
Beckman Coulter is recalling AU2700/AU2700 Plus & AU5400 Clinical Chemistry Analyzers becuase it was determined that the tubing/joint connections associated with these MODs may leak concentrated detergent. Beckman Coulter has received complaints that the joint connecting the tubing appears to disintegrate over time, causing a leak.
Which lots are affected?
All Serial Numbers Model Numbers: AU2700, AU27000ISE, AU5421, AU5421ISE, AU5431. Part Numbers: E0750053 N3663400 N3663700 N3664000 N3664200 N3664400 N3664600 N3664800 N3878500 1465600 64270G E61DAU2700 N3663500 N3663600 N3663800 N3663900 N3664100 N3664300 N3664500 N3664700 N3664900 N3878600 O9102700 N3665000 N3665100 N3665200 N3665300 N3665400 N3878300 64542 A94504 N1683100 AU5431-U1 N3665500 N3665600 N3665700 N3665800 N3665900 N3878400
Where was it sold?
Worldwide Distribution-USA Nationwide and countries of: AU, CA, DE, ES, GB, IT, PT, and JP.
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.
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