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U.S. Department of Health and Human Services

Class 3 Device Recall Abbott RealTime CT/NG Assay

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 Class 3 Recall
Abbott RealTime CT/NG Assay
see related information
Date Posted February 23, 2011
Recall Status1 Terminated on November 19, 2012
Recall Number Z-1397-2011
Recall Event ID 57431
Premarket Notification
510(K) Number
K092704 
Product Classification Dna-Reagents, Chlamydia - Product Code LSK
Product Abbott RealTime CT/NG Assay, List 8L07, in vitro diagnostic; Abbott Molecular Inc., Des Plaines, IL 60018 USA The Abbott RealTime CT/NG assay is an in vitro polymerase chain reaction (PCR) assay for the direct, qualitative detection of the plasmid DNA for C. trachomatis and the genomic DNA of N. gonorrhoeae in female endocervical or vaginal swab specimens, male urethral swab specimens, or in male and female urine specimens.
Code Information All in date lots
Recalling Firm/
Manufacturer
Abbott Molecular
1300 E Touhy Ave
Des Plaines, Illinois 60018-3315
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/UNDETERMINED: Pending
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 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 = LSK and Original Applicant = ABBOTT MOLECULAR, INC.
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