Siemens Healthcare Diagnostics, Inc recalls Siemens Calibrator E; SMN 10309079 (2 pack), SMN 10321075 (6 pack), SMN 10335532 (6 pack Ref)

Recalled November 12, 2014 · FDA recall Z-0164-2015 · Siemens Healthcare Diagnostics

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. · FDA Class II

Units

Total = 19,352 (13,881 - 2 pack, 4878 - 6 pack, 593 - 6 pack REF)

Sold at

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

Description

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.

Product

Siemens Calibrator E; SMN 10309079 (2 pack), SMN 10321075 (6 pack), SMN 10335532 (6 pack Ref)

Manufacturer(s)

Siemens Healthcare Diagnostics, Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →