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SPECIAL STAINS AFB III STAINING KIT (2017-10-24)
- Starting date:
- October 24, 2017
- Posting date:
- November 10, 2017
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- Healthcare Professionals, General Public, Hospitals
- Identification number:
- RA-65080
Affected products
SPECIAL STAINS AFB III STAINING KIT
Reason
During an internal stability monitoring study on AFB III Staining Kit, some artifact consisting of spherical aggregates of colored background was observed. The investigation showed that the opened AFB stain vial was stable for 6 months.
Affected products
SPECIAL STAINS AFB III STAINING KIT
Lot or serial number
All lots
Model or catalog number
860-027
Companies
- Manufacturer
-
Ventana Medical Systems Inc.
1910 E Innovation Park Drive,
Tucson
85755
Arizona
UNITED STATES