Device product
Siemens Calibrator E; SMN 10309079 (2 pack), SMN 10321075 (6 pack), SMN 10335532 (6 pack Ref)
Z-0164-2015
Product summary
- Event
- Event 69430
- Status
- Terminated
- Classification
- Class II
- Quantity
- Total = 19,352 (13,881 - 2 pack, 4878 - 6 pack, 593 - 6 pack REF)
- Official record key
device-enforcement:Z-0164-2015
Official wording
Reason: 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.
Code information: 26284A38, 26900A38, 27991A38, 28192A38, 29571A38, 31162A38, 32488A38, 35243AB39, 35295AB39, 36091AB39, 39464AB39, 40245AB39, 41317AB39, 26285A38, 27348A38, 29169A38, 30710A38, 31261A38, 32687A38, 35259AB39, 35359AB39, 36289AB39, 39031AB39, 41124AB39, 27236A38, 35051A38, 35839AB39, 40141AB39, 41702AB39
Distribution pattern: 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
Derived failure modes
-
Unknown
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.