Reported Jun 5, 2013 · Terminated
AU2700 Clinical Chemistry Analyzer AU5400 Clinical Chemistry Analyzer Perform automated analysis of serum, urine, and…
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?
- AU2700 Clinical Chemistry Analyzer AU5400 Clinical Chemistry Analyzer Perform automated analysis of serum, urine, and other body fluids, including whole blood.
- Lot codes and dates
- All Serial Numbers Model Numbers
AU2700AU27000ISEAU5421AU5421ISEAU5431
- Part Numbers
E0750053N3663400N3663700N3664000N3664200N3664400N3664600N3664800N3878500146560064270GE61DAU2700N3663500N3663600N3663800N3663900N3664100N3664300N3664500N3664700N3664900N3878600O9102700N3665000N3665100N3665200N3665300N3665400N387830064542A94504N1683100AU5431-U1N3665500N3665600N3665700N3665800N3665900N3878400
- All Serial Numbers Model Numbers
- Amount recalled
- 108 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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