Beckman Coulter Inc.: Medical Device Recall in 2016 - (Recall #: Z-0648-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: October 19, 2016

Date Posted: November 30, 2016

Recall Number: Z-0648-2017

Event ID: 75503

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.

Status: Terminated

Product Quantity: 2367 units total (207 units in US)

Code Information:

6040014K 6040015K

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated