FDAFDA · Food and drugs·Recall number Z-1118-2013
Clinical Chemistry Phenobarbital, list number 1E08
Published April 24, 2013 · Recall initiated: November 16, 2012
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
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
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Abbott Laboratories, Inc
- Distributor
- Worldwide Distribution - USA (nationwide) and Internationally to Internationally distributed to Argentina, Australia, Austria, Bahamas, Brunei, Canada, Chile, Curacao, Denmark, France, Germany, Greece, Ireland, Italy, Lebanon, Mexico, Netherlands, Norway, Oman, Paraguay, Portugal, Puerto Rico, Russia, Saudi Arabia, Serbia, South Korea, Spain, Switzerland, Turkey, and United Kingdom.
- Lot
- Lot Numbers 52803UN12, 62299UN12, and 85773UN12
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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