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U.S. Department of Health and Human Services

Enforcement Report - Week of April 24, 2013

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Product Detail

Product Description Clinical Chemistry Phenobarbital, list number 1E08
Recall Number Z-1118-2013
Classification Class II
Code Info Lot Numbers 52803UN12, 62299UN12, and 85773UN12
Product Distributed Qty 1289
Reason For Recall 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 exhibited similar imprecision issues. As a precaution, future replacement lots will have reduced dating until root cause is identified and preventive measures are implemented.

Event Detail

Event Id 63945
Product Type Devices
Status Ongoing
Recalling Firm Abbott Laboratories, Inc
City Irving
State TX
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-11-16
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern 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.