FDA-Device2023-07-05Class II
Access Hybritech p2PSA reagent, REF B03704 and REF A49752.
Beckman Coulter, Inc.
Hazard
Reagent lot numbers include an insufficient concentration of blocking reagent.
Sold states
Distribution was made to CA, CO, CT, FL, GA, IL, IN, MA, MI, NC, NE, NJ, NY, OH, SC, TN, TX, UT, and WA. There was government distribution but no military distribution. Foreign distribution was made to Australia, Austria, Belgium, Brazil, China, Czech Republic, France, Germany, Hong Kong, India, Italy, Japan, Korea, Lithuania, Macao, Mexico, Portugal, Russia, Serbia, Singapore, Slovakia, Spain, Switzerland, Taiwan, and Vietnam.
Affected count
987 kits
Manufactured in
1000 Lake Hazeltine Dr, N/A, Chaska, MN, United States
Products
Access Hybritech p2PSA reagent, REF B03704 and REF A49752.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2043-2023Don't want to check this manually?
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