This page has been archived on the Web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.
COBAS H 232 INSTRUMENTS (2016-04-26)
- Starting date:
- April 26, 2016
- Posting date:
- May 16, 2016
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Hospitals, Healthcare Professionals
- Identification number:
- RA-58370
Affected products
- COBAS H 232 INSTRUMENTS
Reason
Contamination of the mirror from the optical system can lead to false positive signals in the early phase of measurement which can lead to the following failure pattern on a cobas h 232: "TnT elevated" displayed during the measurement but the final results is trop T (less than) 50ng/l, IQC level-II fails, E-402 during a measurement.
Affected products
-
COBAS H 232 INSTRUMENTS
Lot or serial number
More than 100 numbers, contact manufacturer.
Model or catalog number
- 4901142190
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY