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AFB III Staining Kit (2014-11-03)
- Starting date:
- November 3, 2014
- Posting date:
- November 20, 2014
- 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-42167
Recalled Products
AFB III Staining Kit
Reason
A staining artefact has been observed on stained slides that may interfere with the interpretation and identification of acid-fast bacteria (AFB), which is the indication for this assay. This artefact can be described as circular, non-specific purplish-color slide background, and the color can vary from blue to pink to purple. The staining artefact has the potential for obstructing visualization of acid-fast bacteria, therefore leading to the potential for false positive or negative results.
Affected products
AFB III Staining Kit
Lot or serial number
- D05755
- D08323
- D11015
- E01024
- E03378
Model or catalog number
860-027
Companies
- Manufacturer
-
Ventana Medical Systems Inc.
1910 E Innovation Park Drive,
Tucson
85755
Arizona
UNITED STATES