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COAGUCHEK XS PLUS MONITORS ( 2015-07-23)
- Starting date:
- July 23, 2015
- Posting date:
- August 18, 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-54684
Affected Products
- COAGUCHEK XS PLUS MONITOR
- COAGUCHEK XS PLUS MONITOR
Reason
The manufacturer has found a potential situation concerning the CoaguChek XS Plus Meters and the CoaguChek XS Pro Meters where a potential deficiency in providing the approved version of the operator manual when distributed to users.
Affected products
A. COAGUCHEK XS PLUS MONITOR
Lot or serial number
>10. Contact MFR.
Model or catalog number
04800842190
Companies
- Manufacturer
-
Roche Diagnostics Gmbh
Sandhoferstrasse 116
Mannheim
68305
GERMANY
B. COAGUCHEK XS PLUS MONITOR
Lot or serial number
>10. Contact MFR.
Model or catalog number
05448964001
Companies
- Manufacturer
-
Roche Diagnostics Gmbh
Sandhoferstrasse 116
Mannheim
68305
GERMANY