Reported Nov 20, 2013 · Terminated

Access 2 Immunoassay System, Part Number: 81600N The Access Immunoassay System is an in vitro diagnostic device used…

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?

  • Access 2 Immunoassay System
  • Part Number81600N The Access Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids
Lot codes and dates
  • Serial Numbers
    • 508801
    • 508802
    • 508803
    • 508804
    • 508805
    • 508806
    • 508807
    • 508810
Amount recalled
8 units total (1 unit in the US)

Where it was sold

  • Nationwide
  • TX

Why it was recalled

Beckman Coulter is recalling the Access 2 Immunoassay System because they determined that the fuses in the system may be of the wrong amperage.

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 Nov 14, 2013 · Data as of Sep 19, 4:47 PM UTC

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