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Class 2 Device Recall Clinical Chemistry Phenobarbital |
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Date Initiated by Firm |
November 16, 2012 |
Date Posted |
April 15, 2013 |
Recall Status1 |
Terminated 3 on June 18, 2013 |
Recall Number |
Z-1118-2013 |
Recall Event ID |
63945 |
510(K)Number |
K993031
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Product Classification |
Enzyme immunoassay, phenobarbital - Product Code DLZ
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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 TX 75038-4313
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For Additional Information Contact |
Customer Service 877-422-2688
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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
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FDA Determined Cause 2 |
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
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database |
510(K)s with Product Code = DLZ and Original Applicant = SYVA CO.
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