FDA-Device2013-04-24Class II
Clinical Chemistry Phenobarbital, list number 1E08
Abbott Laboratories, Inc
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
Sold states
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.
Affected count
1289
Manufactured in
1921 Hurd Dr, N/A, Irving, TX, United States
Products
Clinical Chemistry Phenobarbital, list number 1E08
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1118-2013Don't want to check this manually?
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