FDA-Device2023-09-06Class II
Beckman Coulter, IVD, REF: OSR61171, IgA, 4 x 14 mL R1, 4 x 11 mL R2
Beckman Coulter Inc.
Hazard
Lipemic interference failed to meet the performance specification listed within the IFU.
Sold states
US: AL AR AZ CA CO CT DC DE FL GA IA IL IN KS KY LA MA MD MI MN MO MS NC ND NE NJ NM NY OH OK OR PA RI SC SD TN TX UT VA WA WI WV OUS: Algeria, Argentina, Australia, Austria, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, China, Colombia, C¿te d'Ivoire, Croatia, Cura¿ao, Cyprus, Czechia, Denmark, Ecuador, Egypt, France, Germany, Gibraltar, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Kazakhstan, Korea, Republic of, Lebanon, Lithuania, Malaysia, Mayotte, Mexico, Morocco, Mozambique, Netherlands, New Zealand, Oman, Pakistan, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russian Federation, San Marino, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Switzerland, Taiwan, Province of China, Tunisia, Turkey, United Arab Emirates, United Kingdom of Great Britain and Northern Ireland, Uruguay, Viet Nam, Yemen.
Affected count
12,850 units
Manufactured in
250 S Kraemer Blvd, N/A, Brea, CA, United States
Products
Beckman Coulter, IVD, REF: OSR61171, IgA, 4 x 14 mL R1, 4 x 11 mL R2
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2488-2023Don't want to check this manually?
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