Vysis LSI p16 (9p21)/CEP 9 (9p11-q11) Dual Color Probe Set; a locus specific identifier DNA probe consisting of a mixtur
FDA device recall Z-0416-06 · posted 2006-01-24 · Terminated
Recall details
- Recalling firm
- Abbott Molecular
- Reason for recall
- The DNA-Probe has a target size of ~300 Kb region instead of the labeled ~190 Kb region.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- MAO
- Quantity affected
- 749 kits
- Distribution
- Nationwide, Germany, Japan, Canada, Korea, India, Malaysia, Australia, Hong Kong, Chile & Singapore
- Date initiated
- 2005-10-28
- Date posted
- 2006-01-24
- Date terminated
- 2006-10-05
- Location
- Des Plaines, IL
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