Reported Apr 10, 2013 · Terminated
Synchron LXi 725 Clinical System; P/N 107405S Product Usage: The Access Immunoassay Systems are in vitro diagnostic…
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?
- Synchron LXi 725 Clinical System
- P/N 107405S Product UsageThe Access Immunoassay Systems are in vitro diagnostic devices used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids
- Lot codes and dates
- Part # A15642; All Serial Numbers
- Amount recalled
- 83 units
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
- Nationwide
Why it was recalled
Beckman Coulter is initiating a recall due to a defective newly released aluminum incubator belt pulley that may rub against the light shield, which causes the formation of debris. Debris that is caused by the incubator belt pulley rubbing against the light shield can fall into the reaction vessels (RVs) and present a risk of erroneous test results.
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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