Various Roche Detection, Amplification Kits and Primary Antibody (2018-08-16)
- Starting date:
- August 16, 2018
- Posting date:
- September 17, 2018
- 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-67748
Affected products
A. iVIEW DAB Detection Kit
B. ISH iVIEW Blue Plus Detection Kit
C. ultraView Universal DAB Detection Kit
D. CONFIRM anti-Progesterone Receptor (PR) (1E2) Rabbit Monoclonal Primary Antibody
E. CONFIRM anti-Estrogen Receptor (ER) (SP1) Rabbit Monoclonal Primary Antibody
F. ultraView Universal Alkaline Phosphatase Red Detection Kit
G. ISH iVIEW Blue Detection Kit
H. anti-Pan Keratin (AE1/AE3/PCK26) Primary Antibody
I. ultraView SISH DNP Detection Kit
J. VENTANA Basal Cell Cocktail (34betaE12)
K. OptiView DAB IHC Detection Kit
L. OptiView Amplification Kit
M. CINtec p16 Histology
N. VENTANA anti-Helicobacter pylori SP48 Rabbit Monoclonal Primary Antibody
O. ISH Protease 3
Reason
Following investigation of customer complaints, the manufacturer confirmed the potential to observe leaking and sticking reagent dispensers that are used on benchmark instruments. This could occur with products intended for greater than 50 actuations and products with emulsifiers. This failure could result in a complete or partial dispense failure of a reagent critical to the staining reaction, potentially leading to erroneous results.
Affected products
A. iVIEW DAB Detection Kit
Lot or serial number
Y24245
Model or catalog number
760-091
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY
B. ISH iVIEW Blue Plus Detection Kit
Lot or serial number
Y15410
Model or catalog number
760-097
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY
C. ultraView Universal DAB Detection Kit
Lot or serial number
Y25695
Model or catalog number
760-500
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY
D. CONFIRM anti-Progesterone Receptor (PR) (1E2) Rabbit Monoclonal Primary Antibody
Lot or serial number
Y12992
Y18852
Y23051
Model or catalog number
790-4296
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY
E. CONFIRM anti-Estrogen Receptor (ER) (SP1) Rabbit Monoclonal Primary Antibody
Lot or serial number
Y18586
Y24472
Model or catalog number
790-4325
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY
F. ultraView Universal Alkaline Phosphatase Red Detection Kit
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
760-501
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY
G. ISH iVIEW Blue Detection Kit
Lot or serial number
Y15105
Y22455
Model or catalog number
800-092
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY
H. anti-Pan Keratin (AE1/AE3/PCK26) Primary Antibody
Lot or serial number
Y21610
Model or catalog number
760-2135
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY
I. ultraView SISH DNP Detection Kit
Lot or serial number
Y26299
Model or catalog number
800-098
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY
J. VENTANA Basal Cell Cocktail (34betaE12)
Lot or serial number
Y20881
Model or catalog number
790-1010
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY
K. OptiView DAB IHC Detection Kit
Lot or serial number
E00119
Y25760
Model or catalog number
760-700
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY
L. OptiView Amplification Kit
Lot or serial number
Y26282
Model or catalog number
860-099
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY
M. CINtec p16 Histology
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
725-4713
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY
N. VENTANA anti-Helicobacter pylori SP48 Rabbit Monoclonal Primary Antibody
Lot or serial number
Y12986
Y16448
Model or catalog number
790-1015
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY
O. ISH Protease 3
Lot or serial number
Y22569
Y25883
Model or catalog number
780-4149
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY