FDA-Device2017-03-22Class II
The ABL800 Model#:All
Radiometer America Inc
Hazard
Reports that the sample type "cord blood" has been changed into the two sample types "cord blood arterial" and "cord blood venous.
Sold states
U.S. distribution to the following; nationwide. Foreign distribution to the following; Netherlands, China, Czech Republic, Denmark, Germany, Spain, France, Hungary, India, Japan, Poland, South Africa, Singapore, Switzerland, Turkey, Norway, Austria, Italy, Sweden, Finland.
Affected count
17,522
Manufactured in
250 S Kraemer Blvd, N/A, Brea, CA, United States
Products
The ABL800 Model#:All
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1463-2017Don't want to check this manually?
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