This page has been archived on the Web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.
VANCOMYCIN ASSAYS (2015-09-04)
- Starting date:
- September 4, 2015
- Posting date:
- October 5, 2015
- 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-55212
Affected Products
- VANC2 (ONLINE TDM VANCOMYCIN FOR ROCHE/HITACHI COBAS C 311 AND C 701/702 SYSTEMS
- VANC2 (ONLINE TDM VANCOMYCIN FOR ROCHE/HITACHI COBAS C 311 AND C 501/502 SYSTEMS
- VANCOMYCIN (ONLINE TDM VANCOMYCIN FOR ROCHE/HITACHI 912 AND MODULAR P ANALYZERS)
Reason
An inaccurately low result was reported for a Vancomycin patient sample on Cobas C501. This was confirmed by Roche. Detailed investigations revealed that the sample contains a component which inhibits the drug labeled enzyme glucose-6-phosphate dehydrogenase (Vanc-G6PDH) in the emit assay.
Affected products
A. VANC2 (ONLINE TDM VANCOMYCIN FOR ROCHE/HITACHI COBAS C 311 AND C 701/702 SYSTEMS
Lot or serial number
All lots.
Model or catalog number
- 5842310190
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY
B. VANC2 (ONLINE TDM VANCOMYCIN FOR ROCHE/HITACHI COBAS C 311 AND C 501/502 SYSTEMS
Lot or serial number
All lots.
Model or catalog number
- 4491050190
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY
C. VANCOMYCIN (ONLINE TDM VANCOMYCIN FOR ROCHE/HITACHI 912 AND MODULAR P ANALYZERS)
Lot or serial number
All lots.
Model or catalog number
- 4642481190
- 4642490190
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY