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Health product recall

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