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U.S. Department of Health and Human Services

Class 3 Device Recall Vysis LSI p16 (9p21)/CEP 9 (9p11q11) Dual Color Probe Set

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 Class 3 Device Recall Vysis LSI p16 (9p21)/CEP 9 (9p11q11) Dual Color Probe Setsee related information
Date Initiated by FirmOctober 28, 2005
Date PostedJanuary 24, 2006
Recall Status1 Terminated 3 on October 05, 2006
Recall NumberZ-0416-06
Recall Event ID 33825
Product Classification Dna-Probe, Human Chromosome - Product Code MAO
ProductVysis LSI p16 (9p21)/CEP 9 (9p11-q11) Dual Color Probe Set; a locus specific identifier DNA probe consisting of a mixture of the LSI p16 probe labeled with a SpectrumOrange and the CEP 9 probe labeled with a SpectrumGreen fluorophore, accompanied with LSI/WCP Hybridization Buffer; 20 evaluations; Vysis Inc., Downers Grove, IL 60515; order number 32-190078
Code Information order number 32-190078, lots 42919, 45942, 53417, 57026, 59938, 60858
FEI Number 3005248192
Recalling Firm/
Manufacturer		 Abbott Molecular
1300 E Touhy Ave
Des Plaines IL 60018
For Additional Information ContactMr. Donald B. Braakman
224-361-7246
Manufacturer Reason
for Recall		The DNA-Probe has a target size of ~300 Kb region instead of the labeled ~190 Kb region.
FDA Determined
Cause 2		Other
ActionAbbott Molecular sent letters dated October 2005 to their direct laboratory accounts on 10/28/05 via first class certified mail. The accounts were informed of the discrepancy between the actual size and region of coverage produced by the affected lots and that described in the product literature. The accounts were instructed to assess the impact of this discrepancy on the use of the product in their laboratory and to retain a copy of the letter with any of the affected product remaining in their inventory.
Quantity in Commerce749 kits
DistributionNationwide, Germany, Japan, Canada, Korea, India, Malaysia, Australia, Hong Kong, Chile & Singapore
Total Product Life CycleTPLC 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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