Health product recall

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