FDAFDA · Food and drugs·Recall number Z-0164-2015
Siemens Calibrator E; SMN 10309079 (2 pack), SMN 10321075 (6 pack), SMN 10335532 (6 pack Ref)
Published November 12, 2014 · Recall initiated: September 26, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Siemens Healthcare Diagnostics, Inc
- Distributor
- 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
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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