Z-0091-2018Class II

AQUIOS CL Flow Cytometer, Catalog No. B30166, Rx. The firm name on the label is Beckman Coulter Ireland Inc...

Name: Z-0091-2018 AQUIOS CL Flow Cytometer, Catalog No. B30166, Rx. The firm name on the label is Beckman Coulter Ireland Inc...
Creator: Beckman Coulter Inc.
Published: 2017-10-02
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2017-10-02 / Terminated / root cause: software

FDA source

Beckman Coulter Inc. began a recall of AQUIOS CL Flow Cytometer, Catalog No. B30166, Rx. The firm name on the label is Beckman Coulter Ireland Inc., Ireland. The AQUIOS CL Flow Cytometer is intended... on 2017-10-02. FDA classified it as Class II and gives the reason as "The system may duplicate sample requests leading to sample misidentification when connected to a Laboratory Information System (LIS)". 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-0091-2018
Classification: Class II
Status: Terminated
Initiated: 2017-10-02
Posted: 2018-10-11
Terminated: 2019-05-08
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: AQUIOS CL Flow Cytometer, Catalog No. B30166, Rx. The firm name on the label is Beckman Coulter Ireland Inc., Ireland. The AQUIOS CL Flow Cytometer is intended for use as an in vitro diagnostic device for immunophenotyping. It is used in conjunction with the following reagents and software package: AQUIOS Tetra-1 Panel monoclonal antibody reagents, AQUIOS Tetra-2+ Panel monoclonal antibody reagents, and AQUIOS CL Flow Cytometry Software.
Product code: OYE Flow Cytometric Reagents And Accessories.
Reason for recall: The system may duplicate sample requests leading to sample misidentification when connected to a Laboratory Information System (LIS)
Root cause tag: software
FDA root cause: Software design
Action: Beckman Coulter sent an Urgent Medical Device Recall letter dated September 28, 2017, and via phone on October 4, 2017. On 11/30/2017, the firm issued an updated letter dated 11/28/2017. The letter informs the customer this letter replaces the instructions in the original notification dated 9/28/2017.
Quantity in commerce: 268 units
Distribution: Worldwide Distribution - US Distribution to the states of : AZ, CA, CO, FL, GA, IL, IN, KS, NC, NY, OR, PA, SC, TX, and WA, including Puerto Rico and government distribution, and to the countries of : Canada, Angola, Australia, Belgium, Botswana, Brazil, Chile, Colombia, Czech Republic, Denmark, Finland, France, Germany, Ghana, Hong Kong, India, Israel, Italy, Kenya, Lesotho, Malawi, Malaysia, Mexico, Namibia, Netherlands, New Zealand, Norway, Pakistan, Panama, Poland, Portugal, Romania, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, Uganda, Ukraine, United Kingdom, and Zambia.
Product codes and lots: All existing software versions (2.0, 2.0.1, and 2.1).

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0091-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0091-2018	Class II	Terminated	Voluntary: Firm initiated	2017-11-22	2017-11-15

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)