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Confirm Anti-S100 (Clone 4C4.9 and Polyclonal Primary Antibody) (2017-02-20)
- Starting date:
- February 20, 2017
- Posting date:
- March 10, 2017
- 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-62496
Affected Products
- Confirm Anti-S100 (Clone 4C4.9)
- Confirm Anti-S100 (Polyclonal) Primary Antibody
Reason
The package inserts of the Confirm Anti-S100 (4C4.9) primary antibody and the Confirm Anti-S100 (polyclonal) primary antibody have been updated to include cell conditioning in the protocol since false negative staining results were observed when cell conditioning was omitted.
Affected products
A. Confirm Anti-S100 (Clone 4C4.9)
Lot or serial number
All lots
Model or catalog number
790-2914
Companies
- Manufacturer
-
Ventana Medical Systems Inc.
1910 E Innovation Park Drive,
Tucson
85755
Arizona
UNITED STATES
B. Confirm Anti-S100 (Polyclonal) Primary Antibody
Lot or serial number
All lots
Model or catalog number
760-2523
Companies
- Manufacturer
-
Ventana Medical Systems Inc.
1910 E Innovation Park Drive,
Tucson
85755
Arizona
UNITED STATES