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Beckman Coulter Inc. recalls BECKMAN COULTER ACCESS Immunoassay Systems - Access Unconjugated Estriol, REF 33570.
Recalled September 30, 2020 · FDA recall Z-3006-2020 · Beckman Coulter
Hazard
Due to alkaline phosphatase (ALP) associated interference causing falsely elevated uE3 (Unconjugated Estriol assay) results. · FDA Class II
Units
21455 assay systems
Sold at
Worldwide distribution - U.S. Nationwide distribution including in the states of AL, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, LA, MA, MD, MI, MN, NC, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, WA, WI and Puerto Rico. The countries of Australia, Belgium, Bosnia and Herzegovina, Brazil, Canada, China, Czech Republic, Germany, Hungary, India, Ireland, Italy, Jordan, Lebanon, Malaysia, Mexico, Nepal, Pakistan, Panama, Portugal, Russia, Saudi Arabia, Serbia, Slovakia, South Africa, South Korea, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, and Vietnam.
Description
Due to alkaline phosphatase (ALP) associated interference causing falsely elevated uE3 (Unconjugated Estriol assay) results.
Product
BECKMAN COULTER ACCESS Immunoassay Systems - Access Unconjugated Estriol, REF 33570.
Manufacturer(s)
Beckman Coulter Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →