Reported Nov 12, 2014 · Terminated
Siemens Calibrator E; SMN 10309079 (2 pack), SMN 10321075 (6 pack), SMN 10335532 (6 pack Ref)
Siemens Healthcare Diagnostics, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Siemens Healthcare Diagnostics, Inc · 333 Coney St · East Walpole, MA · 02032-1516
Is this the product you have?
Siemens Calibrator ESMN 10309079 (2 pack)SMN 10321075 (6 pack)SMN 10335532 (6 pack Ref)
- Lot codes and dates
26284A3826900A3827991A3828192A3829571A3831162A3832488A3835243AB3935295AB3936091AB3939464AB3940245AB3941317AB3926285A3827348A3829169A3830710A3831261A3832687A3835259AB3935359AB3936289AB3939031AB3941124AB3927236A3835051A3835839AB3940141AB3941702AB39
- Amount recalled
- Total = 19,352 (13,881 - 2 pack, 4878 - 6 pack, 593 - 6 pack REF)
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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