FDA Medical Device Recalls (openFDA)
Beckman Coulter Inc.: AQUIOS CL Flow Cytometer System The AQUIOS CL Flow Cytometer is intended for use as an in vitro diagnostic device for immunophenotyping.
- Recall number
- Z-3135-2017
- Recalling firm
- Beckman Coulter Inc.
- Product
- AQUIOS CL Flow Cytometer System The AQUIOS CL Flow Cytometer is intended for use as an in vitro diagnostic device for immunophenotyping.
- Status
- Terminated
- Initiated
- 2017-08-21
- Posted
- not on file
- Terminated
- 2023-09-27
- Reason
- 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.
- Root cause
- Under Investigation by firm
- Action
- The firm, Beckman Coulter, sent an "URGENT MEDICAL DEVICE RECALL" letter dated August 16, 2017 to the affected customers via email, mail, and phone during the week of August 21, 2017. The letter described the product, problem and actions to be taken. The customers are instructed to follow instructions provided in the letter and complete and return the Customer Response Form within 10 days via Fax to: (786)-639-7500 /7501 /7502 /7504; mail to: Beckman Coulter, Inc.,- Attn: Regulatory Affairs Mail Code 31-B06; 11800 S.W. 147th Avenue; P O BOX 169015, Miami, FL 33116-9015 or email (if received electronically) at: Regulatory.Notifications@beckmancoulter.com -include in subject field: FA-31696 AQUIOS CL August 2017. If you have any questions regarding this notification, please contact: From our website: http://www.beckmancoulter.com By phone: call 800-369-0333 in the United States and Canada. By email: LScustomerLetter@Beckman.com Outside the United States and Canada, contact your local Beckman Coulter representative.
- Quantity
- 213 units (34 units in the US)
- Distribution
- 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, serial or model codes
- 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
- 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