Chemstrip 5, Chemstrip 7 and Urisys 1100 (2018-08-27)
- Starting date:
- August 27, 2018
- Posting date:
- November 28, 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-68374
Affected Products
- Chemstrip 5
- Chemstrip 7
- Urisys 1100
Reason
A deviation was found in measuring performance for above listed test strip products, when measured on Urisys 1100 Urine Analyzer. The performance for Limit of Detection (LoD) of parameter Protein, Nitrite, Leukocytes and Erythrocytes does not correspond to the values listed in the respective registration documents. The discrepant LoD can lead to false negative results at the limit of detection level, for affected parameters (Protein, Nitrite, Leukocytes or Blood (intact erythrocytes)).
Affected products
A. Chemstrip 5
Lot or serial number
All lots.
Model or catalog number
- 11893467119
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY
B. Chemstrip 7
Lot or serial number
All lots.
Model or catalog number
- 11008552119
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY
C. Urisys 1100
Lot or serial number
All lots.
Model or catalog number
- 03617548001
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY