Z-0648-2017Class II

AQUIOS Lyse Reagent Kit, Catalog No. B23538

Name: Z-0648-2017 AQUIOS Lyse Reagent Kit, Catalog No. B23538
Creator: Beckman Coulter Inc.
Published: 2016-10-19
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2016-10-19 / Terminated

FDA source

Beckman Coulter Inc. began a recall of AQUIOS Lyse Reagent Kit, Catalog No. B23538 Product Usage: AQUIOS Lysing Reagent Kit is used as part of the AQUIOS flow cytometer system. The kit consists of... on 2016-10-19. FDA classified it as Class II and gives the reason as "Beckman Coulter is recalling the AQUIOS Lyse Reagent Kit because it may lead to an increased generation of notifications and flags when used on the AQUIOS CL when running the AQUIOS Tetra application. The issue could...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0648-2017
Classification: Class II
Status: Terminated
Initiated: 2016-10-19
Posted: 2016-11-21
Terminated: 2017-02-24
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: AQUIOS Lyse Reagent Kit, Catalog No. B23538 Product Usage: AQUIOS Lysing Reagent Kit is used as part of the AQUIOS flow cytometer system. The kit consists of two reagents used by AQUIOS flow cytometers to prepare whole blood samples for analysis of white blood cells.
Product code: OYE Flow Cytometric Reagents And Accessories.
Reason for recall: Beckman Coulter is recalling the AQUIOS Lyse Reagent Kit because it may lead to an increased generation of notifications and flags when used on the AQUIOS CL when running the AQUIOS Tetra application. The issue could lead to an increase in the number of samples requiring review and re-runs with a potential delay to the reporting of results. Depending on the specimen age, a new blood specimen may be required.
FDA root cause: Under Investigation by firm
Action: Beckman Coulter sent an Urgent Medical Device Recall letter dated October 19, 2016 to customers. The letter identified the affected product, problem and actions to be taken. Customers are instructed to complete and return the enclosed Response Form within 10 days. Customers with any questions regarding the notice are instructed to contact our Customer Support Center http://www.beckmancoulter.com/customersupport/support; 1-800-369-0333 in the US and Canada; outside the US and Canada contact local Beckman Coulter Representative.
Quantity in commerce: 2367 units total (207 units in US)
Distribution: Worldwide Distribution - US Nationwide and the countries of Belgium, Botswana, Canada, Chile, Columbia, Czech Republic, Denmark, Finland, France, Germany, Ghana, Italy, Malaysia, Netherlands, Poland, Romania, Slovakia, South Africa, Spain, Sweden, Switzerland, United Kingdom and Zambia
Product codes and lots: 6040014K 6040015K

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0648-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0648-2017	Class II	Terminated	Voluntary: Firm initiated	2016-11-30	2016-11-21

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)