iVIEW DAB, ultraView Universal DAB, ultraView SISH DNP, OptiView DAB IHC Detection Kit and OptiView Amplification Kit, CINtec PLUS Cytology Kit, Hematoxylin II (2017-12-27)
- Starting date:
- December 27, 2017
- Posting date:
- January 12, 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-65668
Affected products
- iVIEW DAB Detection Kit
- ultraView Universal DAB Detection Kit
- ultraView SISH DNP Detection Kit
- OptiView DAB IHC Detection Kit
- OptiView Amplification Kit
- CINtec PLUS Cytology Kit
- Hematoxylin II
Reason
Related to customer complaint investigation, a potential situation concerning dispenser issues with Hematoxylin II and Horseradish peroxidase reagents where it was reported that these reagents dispensers could be leaking or sticking. 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
More than 10 numbers, contact manufacturer.
Model or catalog number
760-091
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY
B. ultraView Universal DAB Detection Kit
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
760-500
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY
C. ultraView SISH DNP Detection Kit
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
790-2208
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY
D. OptiView DAB IHC Detection Kit
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
800-098
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY
E. OptiView Amplification Kit
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
760-700
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY
F. CINtec PLUS Cytology Kit
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- 760-099
- 860-099
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY
G. Hematoxylin II
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
605-100
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY