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U.S. Department of Health and Human Services

Class 2 Device Recall Clinical Chemistry Phenobarbital

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 Class 2 Recall
Clinical Chemistry Phenobarbital
see related information
Date Posted April 15, 2013
Recall Status1 Terminated on June 18, 2013
Recall Number Z-1118-2013
Recall Event ID 63945
Premarket Notification
510(K) Number
K993031 
Product Classification Enzyme Immunoassay, Phenobarbital - Product Code DLZ
Product Clinical Chemistry Phenobarbital, list number 1E08
Code Information Lot Numbers 52803UN12, 62299UN12, and 85773UN12
Recalling Firm/
Manufacturer
Abbott Laboratories, Inc
1921 Hurd Dr
Irving, Texas 75038-4313
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Customer Service
877-422-2688
Manufacturer 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 exhibit
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action Abbott Laboratories sent an Immediate Action Required Product Recall letter dated November 16, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to discontinue use and destroy any remaining inventory of the affected product in accordance with their institution's policies and procedures, order replacement lot 27426UN12 which will expire 18 DEC 2012, and is the only lot currently available (Additional lots will be available in December and January), and complete and return the enclosed Customer Reply Form. If lots were forwarded to another laboratory, a copy of the letter should be forwarded to them. For questions regarding this recall call 1-877-4ABBOTT. For customers outside of the US they should contact their local area Customers Service.
Quantity in Commerce 1289
Distribution 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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = DLZ and Original Applicant = SYVA CO.
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