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.
FDA Recall Z-0648-2017 · Posted 2016-11-21
Recalling FirmBeckman Coulter Inc.
Recall StatusTerminated
Product CodeOYE
Date Initiated2016-10-19
Date Terminated2017-02-24
Product Quantity2367 units total (207 units in US)
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.
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.
Root Cause
Under Investigation by firm
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
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.