—#162185

Product

AQUIOS CL Flow Cytometer System, Catalog #B30166. The AQUIOS CL Flow Cytometer system is an automated analyzer that use a no-wash sample preparation process.The firm name on the label is Beckman Coulter Ireland, Inc., Co. Clare, Ireland.

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

Why it was recalled

The device may process the same sample with two different sample IDs and sample information while using the single tube loader, which has the potential for erroneous results due to the mis-identification.

Root cause (FDA determination)

Software design

Action the firm took

The recalling firm issued letters dated 1/25/2018 via email on 1/31/2018 or to some customers via regular mail during the week of 1/29/2018.

Recalling firm

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

Distribution

Distribution pattern: Distribution was made nationwide in the U.S. and in Puerto Rico. There was also government distribution, but no military distribution. Foreign distribution was made to Angola, Australia, Belgium, Botswana, Brazil, Canada, Chile, Colombia, Czech Republic, Denmark, Finland, France, Germany, Ghana, Hong Kong, India, Israel, Italy, Japan, Kazakhstan, Kenya, Lesotho, Malawi, Malaysia, Mexico, Namibia, Netherlands, New Zealand, Norway, Pakistan, Panama, Poland, Portugal, Romania, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, Uganda, Ukraine, United Kingdom, and Zambia.

Timeline

Recall initiated: 2018-01-29
Terminated: 2019-06-27
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #162185. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.