Reported Apr 24, 2013 · Terminated
Clinical Chemistry Phenobarbital, list number 1E08
Abbott Laboratories, 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: Abbott Laboratories, Inc · 1921 Hurd Dr · Irving, TX · 75038-4313
Is this the product you have?
- Clinical Chemistry Phenobarbital, list number 1E08
- Lot codes and dates
Lot Numbers 52803UN1262299UN12and 85773UN12
- Amount recalled
- 1289
Where it was sold
- Nationwide
- PR
Why it was recalled
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
This product could cause temporary or reversible health problems — stop using it.
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