Z-1341-2018Class II

AQUIOS CL Flow Cytometer System, Catalog #B30166. The AQUIOS CL Flow Cytometer system is an automated...

Name: Z-1341-2018 AQUIOS CL Flow Cytometer System, Catalog #B30166. The AQUIOS CL Flow Cytometer system is an automated...
Creator: Beckman Coulter Inc.
Published: 2018-01-29
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2018-01-29 / Terminated / root cause: software

FDA source

Beckman Coulter Inc. began a recall of AQUIOS CL Flow Cytometer System, Catalog #B30166. The AQUIOS CL Flow Cytometer system is an automated analyzer that use a no-wash sample preparation... on 2018-01-29. FDA classified it as Class II and gives the reason as "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". 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-1341-2018
Classification: Class II
Status: Terminated
Initiated: 2018-01-29
Posted: 2018-04-10
Terminated: 2019-06-27
Recalling firm: Siemens Healthcare Diagnostics 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.
Product code: OYE Flow Cytometric Reagents And Accessories.
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.
Root cause tag: software
FDA 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 in commerce: 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.
Product codes and lots: All software versions.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1341-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1341-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-18	2018-04-10

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)