CLASS II Device recall · Reported 18 Apr 2018 · FDA Enforcement Report
Aquios CL Flow Cytometer System recalled by Beckman Coulter
Beckman Coulter is recalling Aquios CL Flow Cytometer System, distributed nationwide in the US. The recall was initiated on 29 Jan 2018 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1341-2018
- FDA event ID
- 79381
- Recalling firm
- Beckman Coulter, Brea, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 29 Jan 2018
- FDA classified
- 10 Apr 2018
- Reported
- 18 Apr 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Test Kits & Diagnostics
Timeline
| 29 Jan 2018 | Recall initiated by company | |
| 10 Apr 2018 | Classified by FDA | +71 days |
| 18 Apr 2018 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The device may process the same sample with two different sample IDs and sample information while using the single tube loader, which has the potential for erroneous results due to the mis-identification.
Product as listed by the FDA
AQUIOS CL Flow Cytometer System, Catalog #B30166. The AQUIOS CL Flow Cytometer system is an automated analyzer that use a no-wash sample preparation process.The firm name on the label is Beckman Coulter Ireland, Inc., Co. Clare, Ireland.
Where it was distributed
Distribution was made nationwide in the U.S. and in Puerto Rico. There was also government distribution, but no military distribution. Foreign distribution was made to Angola, Australia, Belgium, Botswana, Brazil, Canada, Chile, Colombia, Czech Republic, Denmark, Finland, France, Germany, Ghana, Hong Kong, India, Israel, Italy, Japan, Kazakhstan, Kenya, Lesotho, Malawi, Malaysia, Mexico, Namibia, Netherlands, New Zealand, Norway, Pakistan, Panama, Poland, Portugal, Romania, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, Uganda, Ukraine, United Kingdom, and Zambia.
Questions about this recall
Is Aquios CL Flow Cytometer System recalled?
Yes. Beckman Coulter recalled Aquios CL Flow Cytometer System on 29 Jan 2018. The recall is Class II and its status is Terminated. Recall number Z-1341-2018.
Why was it recalled?
The device may process the same sample with two different sample IDs and sample information while using the single tube loader, which has the potential for erroneous results due to the mis-identification.
Which lots are affected?
All software versions.
Where was it sold?
Distribution was made nationwide in the U.S. and in Puerto Rico. There was also government distribution, but no military distribution. Foreign distribution was made to Angola, Australia, Belgium, Botswana, Brazil, Canada, Chile, Colombia, Czech Republic, Denmark, Finland, France, Germany, Ghana, Hong Kong, India, Israel, Italy, Japan, Kazakhstan, Kenya, Lesotho, Malawi, Malaysia, Mexico, Namibia, Netherlands, New Zealand, Norway, Pakistan, Panama, Poland, Portugal, Romania, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, Uganda, Ukraine, United Kingdom, and Zambia.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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