Abbott Aeroset Phenobarbital Assey and Calibrators;models 1E08 and 5F54

• • Terminated Z-1118-2013 FDA Class II ·initiated 16 Nov 2012

  Abbott Diagnostics is recalling Clinical Chemistry Phenobarbital reagent lots 62299UN12 and 85773UN12 due to imprecision issues which increase with the age of the reagent lot. The imprecision of the Phenobarbital assay is d 7% Total CV%; however, internal testing confirmed CVs up to approximately 12% for in-date reagent lots over five months old. Although lot 52803UN12 is now expired, it exhibit

• • Terminated Z-0454-2007 FDA Unclassified (pre-2012) ·initiated 26 Sep 2006

  Erratic elevated results and or the inability to calibrate due to imprecision.

510(k) Number

K993031 ↗

FDA Product Code

DLZ

Models / Variants

Abbott Aeroset Phenobarbital Assey And Calibrators

models 1E08 And 5F54

Device Class

Class II

Regulation

21 CFR Part 862.3660

Advisory Committee

Clinical Toxicology

FDA Decision

SESE Substantially Equivalent

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