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Beckman Coulter, Inc. recalls Access Hybritech p2PSA reagent, REF B03704 and REF A49752.
Recalled July 5, 2023 · FDA recall Z-2043-2023 · Beckman Coulter
Hazard
Reagent lot numbers include an insufficient concentration of blocking reagent. · FDA Class II
Units
987 kits
Sold at
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.
Description
Reagent lot numbers include an insufficient concentration of blocking reagent.
Product
Access Hybritech p2PSA reagent, REF B03704 and REF A49752.
Manufacturer(s)
Beckman Coulter, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →