Reported Sep 27, 2017 · Terminated
AQUIOS CL Flow Cytometer System The AQUIOS CL Flow Cytometer is intended for use as an in vitro diagnostic device for…
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 System The AQUIOS CL Flow Cytometer is intended for use as an in vitro diagnostic device for immunophenotyping.
- Lot codes and dates
All software versionsSerial numbers - BA30048AY20032BA01007AZ19046AZ12030BA25046BA05011AY51072BA01002AZ15044BA30049BA30050BA05015AZ19047BA18029AY47071AZ15038BA23036BA23035AZ23058AZ20057AY47063BA15024BA15023AZ45080BA01010AZ25070AZ32071AZ12033AZ25065AZ25068AY51075AZ19052BA15025
- Amount recalled
- 213 units (34 units in the US)
Where it was sold
- Nationwide
Why it was recalled
Beckman Coulter has identified that an incorrect setting using a proprietary software configuration tool can result in the Sample Prep Probe of the AQUIOS CL drawing aspirant from the wrong tube in a cassette which manifests in incorrect values being reported out of the laboratory for some patient samples.
This product could cause temporary or reversible health problems — stop using it.
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