Reported Nov 22, 2017 · Terminated

AQUIOS CL Flow Cytometer, Catalog No. B30166, Rx. The firm name on the label is Beckman Coulter Ireland Inc., Ireland.…

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, Rx. The firm name on the label is Beckman Coulter Ireland Inc., Ireland. The AQUIOS CL Flow Cytometer is intended for use as an in vitro diagnostic device for immunophenotyping. It is used in conjunction with the
  • following reagents and software packageAQUIOS Tetra-1 Panel monoclonal antibody reagents, AQUIOS Tetra-2+ Panel monoclonal antibody reagents, and AQUIOS CL Flow Cytometry Software
Lot codes and dates
    • All existing software versions (2.0
    • 2.0.1
    • and 2.1)
Amount recalled
268 units

Where it was sold

Why it was recalled

The system may duplicate sample requests leading to sample misidentification when connected to a Laboratory Information System (LIS)

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

Free recall alerts

Get alerted about new Beckman Coulter Inc. recalls

One email when a matching recall is published. No account, no cost, unsubscribe in one click.

Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated May 8, 2019 · Data as of Sep 19, 6:06 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.