Z-0416-06

Vysis LSI p16 (9p21)/CEP 9 (9p11-q11) Dual Color Probe Set; a locus specific identifier DNA probe consisting...

Name: Z-0416-06 Vysis LSI p16 (9p21)/CEP 9 (9p11-q11) Dual Color Probe Set; a locus specific identifier DNA probe consisting...
Creator: Abbott Molecular
Published: 2005-10-28
License: https://open.fda.gov/license/

Abbott Molecular, Inc. / initiated 2005-10-28 / Terminated / root cause: labeling and UDI

FDA source

Abbott Molecular began a recall of 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... on 2005-10-28. The reason FDA records is "The DNA-Probe has a target size of ~300 Kb region instead of the labeled ~190 Kb region". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0416-06
Status: Terminated
Initiated: 2005-10-28
Posted: 2006-01-24
Terminated: 2006-10-05
Recalling firm: Abbott Molecular, Inc.
Product: 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
Product code: MAO Dna-Probe, Human Chromosome
Reason for recall: The DNA-Probe has a target size of ~300 Kb region instead of the labeled ~190 Kb region.
Root cause tag: labeling and UDI
FDA 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 in commerce: 749 kits
Distribution: Nationwide, Germany, Japan, Canada, Korea, India, Malaysia, Australia, Hong Kong, Chile & Singapore
Product codes and lots: order number 32-190078, lots 42919, 45942, 53417, 57026, 59938, 60858

Product code MAO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)