Z-2900-2016Class II

AQUIOS CL Flow Cytometer, Catalog No. B30166; Intended for use with in vitro diagnostic flow cytometry...

Name: Z-2900-2016 AQUIOS CL Flow Cytometer, Catalog No. B30166; Intended for use with in vitro diagnostic flow cytometry...
Creator: Beckman Coulter Inc.
Published: 2016-09-06
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2016-09-06 / Terminated / root cause: software

FDA source

Beckman Coulter Inc. began a recall of AQUIOS CL Flow Cytometer, Catalog No. B30166; Intended for use with in vitro diagnostic flow cytometry applications using up to four florescent detection... on 2016-09-06. FDA classified it as Class II and gives the reason as "Beckman Coulter is recalling the AQUIOS CL System because the use of the reagent carousel can lead to misalignment of the carousel and damage to the prep probe". 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-2900-2016
Classification: Class II
Status: Terminated
Initiated: 2016-09-06
Posted: 2016-09-28
Terminated: 2017-08-07
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: AQUIOS CL Flow Cytometer, Catalog No. B30166; Intended for use with in vitro diagnostic flow cytometry applications using up to four florescent detection channels.
Product code: OYE Flow Cytometric Reagents And Accessories.
Reason for recall: Beckman Coulter is recalling the AQUIOS CL System because the use of the reagent carousel can lead to misalignment of the carousel and damage to the prep probe.
Root cause tag: software
FDA root cause: Software Design Change
Action: An Urgent Medical Device Recall letter dated 9/6/16 was sent to customers to inform them that the use of Positions 9 and 10 of the reagent carousel can lead to misalignment of the carousel and damage to the prep probe. The letter informs the customers of the impact of the recall, action to be taken, and the resolution by Beckman Coulter. Customers are instructed to complete and return the enclosed Response Form within 10 days. Customers with any questions regarding this notice, are instructed to contact Customer Support Center: http://www.beckmancoulter.com/customersupport/support; call 1-800-369-0333 in the US and Canada; outside the US and Canada, contact their local Beckman Coulter Representative.
Quantity in commerce: 148 units total (12 units in US)
Distribution: US: IL, PA, NY, GA, WA, FL, SC. Affected geographies: Angola, Australia, Belgium, Botswana, Canada, Chile, Columbia, Czech Republic, Denmark, Finland, France, Germany, Ghana, Israel, Italy, Malaysia, Nambia, Netherlands, Panama, Poland, Romania, Slovakia, South Africa, Spain, Sweden, Switzerland, Uganda, United Kingdom and Zambia
Product codes and lots: AY20032 AZ19046 AZ12030 AY51072 AZ19047 AZ15044 AY47071 AZ15038 AY47063 AZ12033 AZ19052 AY51075 AY03004 AZ12027 AY25038

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2900-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2900-2016	Class II	Terminated	Voluntary: Firm initiated	2016-10-05	2016-09-28

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)