Reported Oct 5, 2016 · Terminated

AQUIOS CL Flow Cytometer, Catalog No. B30166; Intended for use with in vitro diagnostic flow cytometry applications…

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?

  • AQUIOS CL Flow Cytometer, Catalog No. B30166; Intended for use with in vitro diagnostic flow cytometry applications using up to four florescent detection channels.
Lot codes and dates
    • AY20032
    • AZ19046
    • AZ12030
    • AY51072
    • AZ19047
    • AZ15044
    • AY47071
    • AZ15038
    • AY47063
    • AZ12033
    • AZ19052
    • AY51075
    • AY03004
    • AZ12027
    • AY25038
Amount recalled
148 units total (12 units in US)

Where it was sold

Why it was recalled

Beckman Coulter is recalling the AQUIOS CL System because the use of the reagent carousel can lead to misalignment of the carousel and damage to the prep probe.

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 Aug 7, 2017 · Data as of Sep 19, 6:46 PM UTC

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