This page has been archived on the Web
Information identified as archived is provided for reference, research or recordkeeping purposes. It is not subject to the Government of Canada Web Standards and has not been altered or updated since it was archived. Please contact us to request a format other than those available.
INFORM HER2 DUAL ISH DNA PROBE COCKTAIL (2016-04-06)
- Starting date:
- April 6, 2016
- Posting date:
- May 16, 2016
- 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-58316
Affected products
- INFORM HER2 DUAL ISH DNA PROBE COCKTAIL
Reason
The method sheet (US Reviewed) of the INFORM HER2 Dual ISH DNA probe cocktail might have been distributed instead of the version that is provided under the Canada folio as indicated on the reagent kit (version enrevb).
Affected products
INFORM HER2 DUAL ISH DNA PROBE COCKTAIL
Lot or serial number
all lots
Model or catalog number
- 800-4422
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY