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VYSIS SPECTRUM AQUA FISH PROBE KIT (2016-03-23)
- Starting date:
- March 23, 2016
- Posting date:
- April 4, 2016
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-57768
Affected Products
VYSIS SPECTRUM AQUA FISH PROBE KIT
Reason
It has been recently identified that the Vysis LSI 9q34 SpectrumAqua FISH Probe Kit is no longer meeting Abbott Molecular's product quality specifications for specificity and background. As a result, non-specific fluorescent particles (aqua speckling) and/or background may interfere with signal interpretation.
Affected products
VYSIS SPECTRUM AQUA FISH PROBE KIT
Lot or serial number
456744
Model or catalog number
05N53-020
Companies
- Manufacturer
-
Abbott Molecular Inc.
1300 E. Touhy Ave.
Des Plaines
60018
Illinois
UNITED STATES