CoaguChek XS Pro and Plus, Cobas H 232 Instruments (2017-12-18)
- Starting date:
- December 18, 2017
- Posting date:
- January 29, 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-65724
Affected products
- CoaguChek XS Plus
- Cobas H 232 Instruments
- CoaguChek XS Pro
Reason
Potential issue with imprecise touch screen response for the meters, which could lead to incorrect data entry. This issue would only occur in the manual patient ID entry screen or in the date and time entry after a meter reset. If this issue occurs, a patient ID mismatch could take place.
Affected products
A. CoaguChek XS Plus
Lot or serial number
All
Model or catalog number
4800842190
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY
B. Cobas H 232 Instruments
Lot or serial number
KS02XXXXX (HBM3)
Model or catalog number
4901142190
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY
C. CoaguChek XS Pro
Lot or serial number
All
Model or catalog number
5530199190
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY