FDA-Device2018-04-18Class II
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.
Beckman Coulter Inc.
Hazard
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.
Sold states
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.
Affected count
288 devices
Manufactured in
250 S Kraemer Blvd, Brea, CA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1341-2018Don't want to check this manually?
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