Z-3135-2017Class II

AQUIOS CL Flow Cytometer System The AQUIOS CL Flow Cytometer is intended for use as an in vitro diagnostic...

Name: Z-3135-2017 AQUIOS CL Flow Cytometer System The AQUIOS CL Flow Cytometer is intended for use as an in vitro diagnostic...
Creator: Beckman Coulter Inc.
Published: 2017-08-21
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2017-08-21 / Terminated / root cause: software

FDA source

Beckman Coulter Inc. began a recall of AQUIOS CL Flow Cytometer System The AQUIOS CL Flow Cytometer is intended for use as an in vitro diagnostic device for immunophenotyping on 2017-08-21. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-3135-2017
Classification: Class II
Status: Terminated
Initiated: 2017-08-21
Posted: 2017-09-19
Terminated: 2023-09-27
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: AQUIOS CL Flow Cytometer System The AQUIOS CL Flow Cytometer is intended for use as an in vitro diagnostic device for immunophenotyping.
Product code: OYE Flow Cytometric Reagents And Accessories.
Reason for recall: 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 tag: software
FDA 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: [email protected] -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: [email protected] Outside the United States and Canada, contact your local Beckman Coulter representative.
Quantity in commerce: 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
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3135-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3135-2017	Class II	Terminated	Voluntary: Firm initiated	2017-09-27	2017-09-19

Product code OYE

K141932Class IIAquios Cl Flow Cytometer, Aquios Tetra-1 Panel,aquios Tetra-2+Panel, Aquios Immuno-Trol, Aquios Immuno-Trol Low, AquiosBeckman Coulter, Inc. / cleared 2015-04-10

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)