Recall Z-0416-06 ยท MAO Dna-Probe, Human Chromosome
Abbott Molecular
Vysis 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
| Date | Jan 24, 2006 (initiated Oct 28, 2005) |
| Status | Terminated |
| Reason | The DNA-Probe has a target size of ~300 Kb region instead of the labeled ~190 Kb region. |
| Root cause | Other |
| Action | Abbott 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 | 749 kits |
| Distribution | Nationwide, Germany, Japan, Canada, Korea, India, Malaysia, Australia, Hong Kong, Chile & Singapore |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.