FDA-Device2014-11-12Class II
Siemens Calibrator E; SMN 10309079 (2 pack), SMN 10321075 (6 pack), SMN 10335532 (6 pack Ref)
Siemens Healthcare Diagnostics, Inc
Hazard
Positive bias for Calibrator E lot kits ending in 38 and 39 with the ADVIA Centaur Systems Cortisol and Progesterone assays compared to the respective master curves.
Sold states
Nationwide including Puerto Rico. Worldwide: Afghanistan, Armenia, Austria, Bahrain, Belgium, Bulgaria, Burkina Faso, Canary Islands, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Georgia, Germany, Great Britain, Greece, Hungary, Iran, Iraq, Ireland, Italy, Jordan, Kazakhstan, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Macedonia, Malta, Morocco, Netherlands, Norway, Oman, Pakistan, Poland, Portugal, Qatar, Romania, Russian Fed., Saudi Arabia, Serbia, Slovakia, Spain, Sweden, Switzerland, Turkey, Unit.Arab Emir., Vatican, Yemen, AR, AU, BD, BR, CA , CH, CL, CN, CO, DO, EC, EG, GT, HK, ID, IE, IL, IN, JP, KR, LY, MM, MX, MY, NI, NP, NZ, PE, PH, PY, SA, SG, SV, TH, TW, UY, VN, ZA
Affected count
Total = 19,352 (13,881 - 2 pack, 4878 - 6 pack, 593 - 6 pack REF)
Manufactured in
333 Coney St, N/A, East Walpole, MA, United States
Products
Siemens Calibrator E; SMN 10309079 (2 pack), SMN 10321075 (6 pack), SMN 10335532 (6 pack Ref)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0164-2015Don't want to check this manually?
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