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ARTISAN GROCOTT'S METHENAMINE SILVER (GMS) STAIN (2015-04-28)
- Starting date:
- April 28, 2015
- Posting date:
- July 29, 2015
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-54432
Affected Products
A. ARTISAN GROCOTT'S METHENAMINE SILVER (GMS) STAIN
Reason
Fungal contamination of the stain. Fungal looking organisms appearing after staining, particularly on the periphery of slides, away from the stained tissue. Contaminate confirmed to be fungal, most likely common indoor mold, Wallemia sebi and confined to one reagent. As this kit is indicated for identifying fungal organisms including Pneumocystis jiroveccii, contamination could compromise diagnostic effectiveness of stain.
Affected products
A. ARTISAN GROCOTT'S METHENAMINE SILVER (GMS) STAIN
Lot or serial number
10095053
Model or catalog number
AR176
Companies
- Manufacturer
-
Dako North America, Inc.
6392 via Real
Carpinteria
93013
California
UNITED STATES