Chemstrip 10A and Urisys 1100 Analyzer (2018-05-10)
- Starting date:
- May 10, 2018
- Posting date:
- June 14, 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-67042
Affected products
A. Chemstrip 10A
B. Urisys 1100 Analyzer
Reason
It was discovered during internal performance studies that the Limit Of Detection (LOD) of the Chemstrip 10A needs to be changed since the current performance claim showed deviating values for protein, nitrite, ketone bodies, leukocytes, blood (intact erythrocytes) when measured on Urisys 1100 analyzer.
Affected products
A. Chemstrip 10A
Lot or serial number
All lots.
Model or catalog number
11379208119
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY
B. Urisys 1100 Analyzer
Lot or serial number
All lots.
Model or catalog number
03617548001
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY