FDA Medical Device Recalls (openFDA)
Beckman Coulter Inc.: 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.
- Recall number
- Z-1341-2018
- Recalling firm
- Beckman Coulter Inc.
- Product
- 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.
- Status
- Terminated
- Initiated
- 2018-01-29
- Posted
- not on file
- Terminated
- 2019-06-27
- Reason
- 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.
- Root cause
- Software design
- Action
- The recalling firm issued letters dated 1/25/2018 via email on 1/31/2018 or to some customers via regular mail during the week of 1/29/2018.
- Quantity
- 288 devices
- Distribution
- 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.
- Lot, serial or model codes
- All software versions.
- 510(k) numbers
- ["K141932"]
- PMA numbers
- not on file
- Product code
- OYE
- Firm FEI
- 2050012
- Firm city
- Brea
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28