FDA-Device2016-02-10Class II
ADVIA Centaur PSA Assay; Catalog Number: 06574155/SMN 10310292 (100 test kit) and Catalog Number: 02676506/SMN 10310293 (500 test kit) Product Usage: This in vitro diagnostic assay is intended to quantitatively measure prostate-specific Antigen (PSA) in human serum using the ADVIA Centaur/XP/XPT/CP Systems.
Siemens Healthcare Diagnostics, Inc
Hazard
PSA assay is not meeting the High Dose Hook Effect expectation in the Instructions for Use (IFU).
Sold states
Worldwide - US Nationwide including Puerto Rico, OUS: Albania, Algeria, Angola, Armenia, Austria, Bahrain, Belarus, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Georgia, Germany, Great Britain, Greece, Hungary, Iceland, Iraq, Italy, Jordan, Kazakhstan, Latvia, Lebanon, Lithuania, Luxembourg, Macedonia, Malta, Morocco, Netherlands, Norway, Oman, Pakistan, Philippines, Poland, Portugal, Qatar, Romania, Russian Fed., Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Tunisia, Turkey, Turkmenistan, Unit.Arab Emir., Vatican, AR, AU, BD, BR, CA, CL, CN, CO, DO, EC, GT, HK, ID, IL, IN, JP, KR, LK, MM, MX, MY, NI, NP, NZ, PE, PH, PY, SA, SG, TH, TW, UY, VN and ZA.
Affected count
55,754 kits
Manufactured in
333 Coney St, N/A, East Walpole, MA, United States
Products
ADVIA Centaur PSA Assay; Catalog Number: 06574155/SMN 10310292 (100 test kit) and Catalog Number: 02676506/SMN 10310293 (500 test kit) Product Usage: This in vitro diagnostic assay is intended to quantitatively measure prostate-specific Antigen (PSA) in human serum using the ADVIA Centaur/XP/XPT/CP Systems.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0754-2016Don't want to check this manually?
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