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U.S. Department of Health and Human Services

Class 3 Device Recall Abbott RealTime HIV1 Assay

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  Class 3 Device Recall Abbott RealTime HIV1 Assay see related information
Date Initiated by Firm December 20, 2010
Date Posted February 23, 2011
Recall Status1 Terminated 3 on November 19, 2012
Recall Number Z-1398-2011
Recall Event ID 57431
Product Classification Monitor, test, hiv - Product Code MTL
Product Abbott RealTime HIV-1 Assay, List 6L18, in vitro diagnostic; Abbott Molecular Inc., Des Plaines, IL 60018 USA
The Abbott RealTime HIV-1 assay is an in vitro reverse transcription-polymerase chain reaction (RT-PCR) assay for the quantitation of Human Immunodeficiency Virus type 1 (HIV-1) on the automated m2000 System in human plasma from HIV-1 infected individuals over the range of 40 to 10,000,000 copies/mL. The Abbott RealTime HIV-1 assay is intended for use in conjunction with clinical presentation and other laboratory markers for disease prognosis and for use as an aid in assessing viral response to antiretroviral treatment as measured by changes in plasma HIV-1 RNA levels. This assay is not intended to be used as a donor screening test for HIV-1 or as a diagnostic test to confirm the presence of HIV-1 infection.
Code Information All in date lots
Recalling Firm/
Manufacturer		 Abbott Molecular
1300 E Touhy Ave
Des Plaines IL 60018-3315
For Additional Information Contact
224-361-7133
Manufacturer Reason
for Recall		 Internal testing identified the potential of under filled and over filled enzyme reagent vials which may result in obtaining less than the total number of tests per kit as described on the package insert.
FDA Determined
Cause 2		 Other
Action Abbott Molecular sent a Field Advisory Notice letter to all RealTime HIV-1, CT/NG and HBV assay customers on December 20, 2010, informing them that internal testing identified the potential of under filled and over filled enzyme vials which may result in obtaining less than the total number of tests per kit as described in the package insert. The customers were told that specimens that meet acceptance criteria, per the product labeling are not affected by the situation and are considered valid results, and that the issue has no impact on results for those runs that generate valid results. Any questions were directed to Abbott Technical Support at 1-800-553-7042, Option 2.
Distribution Nationwide Distribution
Total Product Life Cycle TPLC Device Report
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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