FDA-Device2025-02-12Class II
Access PCT Reagent Pack, Catalog Number C53987, when used on Access 2 and UniCel Dxl Immunoassay Systems
Beckman Coulter Inc.
Hazard
Identified reagent lots are experiencing a high rate of calibration failures with failure code of "Max Iterate" on Access 2 and UniCel Dxl Immunoassay Systems. Reporting of results may be delayed due to the time required to achieve a passing calibration curve.
Sold states
Worldwide distribution - US Nationwide and the countries of Austria, Bahrain, Bangladesh, Belgium, Bosnia and Herzegovina, Brazil, Canada, Chile, China, Croatia, Czechia, Denmark, France, Germany, Greece, Hungary, India, Ireland, Italy, Kazakhstan, Korea, Republic of, Malaysia, Mexico, Peru, Philippines, Poland, Puerto Rico, Romania, Slovakia, South Africa, Spain, Switzerland, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom of Great Britain and Northern Ireland, Viet Nam.
Affected count
6,994 US; 10,067 OUS
Manufactured in
250 S Kraemer Blvd, Brea, CA, United States
Products
Access PCT Reagent Pack, Catalog Number C53987, when used on Access 2 and UniCel Dxl Immunoassay Systems
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1112-2025Don't want to check this manually?
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