FDAFDA · Food and drugs·Recall number Z-3135-2017
AQUIOS CL Flow Cytometer System The AQUIOS CL Flow Cytometer is intended for use as an in vitro diagnostic device for immunophenotyping.
Published September 27, 2017 · Recall initiated: August 21, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Beckman Coulter Inc.
- Distributor
- Worldwide Distribution: United States (nationwide) and countries of: Angola, Australia, Botswana, Canada, Chile, Columbia, Ghana, Israel, Malaysia, Namibia, Pakistan, Panama, South Africa, Uganda, France, Switzerland, Poland, Portugal, Germany, Belgium, Finland, Czech Republic, Denmark, Netherland, Turkey, Spain, Great Britain, Romania, Brazil, Italy, Sweden, Ghana, Colombia, Lesotho and Zambia
- Lot
- All software versions.; Serial numbers - BA30048, AY20032, BA01007, AZ19046, AZ12030, BA25046, BA05011, AY51072, BA01002, AZ15044, BA30049, BA30050, BA05015, AZ19047, BA18029, AY47071, AZ15038, BA23036, BA23035, AZ23058, AZ20057, AY47063, BA15024, BA15023, AZ45080, BA01010, AZ25070, AZ32071, AZ12033, AZ25065, AZ25068, AY51075, AZ19052, BA15025
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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