—#150558

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.

FDA product code: OYE — Flow Cytometric Reagents And Accessories.
Device class: Class 2
Medical specialty: Hematology
510(k) numbers: K141932
Affected lot / code info: 6040014K 6040015K

Why it was recalled

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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: Beckman Coulter Inc.
Address: 250 S Kraemer Blvd, Brea, California 92821-6232

Distribution

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

Timeline

Recall initiated: 2016-10-19
Posted by FDA: 2016-11-21
Terminated: 2017-02-24
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #150558. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.