FDA-Device2015-03-11Class II
ADVIA Centaur Systems Progesterone Kit, (5 -pack); In Vitro Diagnostic; Catalog number: 01586287; SMN:10315522.
Siemens Healthcare Diagnostics, Inc
Hazard
ADVIA Centaur Systems Progesterone Kit Lots Ending in 268 have a high bias on results greater than 30 ng/mL (95.4 nmol/L)
Sold states
Worldwide Distribution-US (nationwide), Austria, Bahrain, Belgium, Bulgaria, Brazil, Canada, Chile, Colombia, Croatia, Cyprus, Czech, Republic, Denmark, Egypt, Estonia, France, Georgia, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Iran, Iraq, Ireland, Italy, Japan, Jordan, Kazakhstan, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Macedonia, Mexico, Morocco, Netherlands, Norway, Oman, Pakistan, Peru, Poland, Portugal, Qatar, Romania, Russian Federation, Serbia, Slovakia, Spain, South America, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, and Vatican.
Affected count
11980 kits
Manufactured in
333 Coney St, N/A, East Walpole, MA, United States
Products
ADVIA Centaur Systems Progesterone Kit, (5 -pack); In Vitro Diagnostic; Catalog number: 01586287; SMN:10315522.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1230-2015Don't want to check this manually?
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