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CHEMSTRIPS (2016-09-14)
- Starting date:
- September 14, 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, Healthcare Professionals, Hospitals
- Identification number:
- RA-60540
Affected Products
A. CHEMSTRIP 9
B. CHEMSTRIP GP
C. CHEMSTRIP 10
D. CHEMSTRIP 5
E. CHEMSTRIP 7
Reason
This recall/product correction is related to incorrect wording in the method sheets of all current lots of Chemstrip products. Specific germs which are clearly gram-negative are falsely classified as gram-positive. The chemistry of strip measurement system and the performance of the product is not affected.
Affected products
A. CHEMSTRIP 9
Lot or serial number
All lots.
Model or catalog number
10398411119
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY
B. CHEMSTRIP GP
Lot or serial number
All lots.
Model or catalog number
10200743119
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY
C. CHEMSTRIP 10
Lot or serial number
All lots.
Model or catalog number
11203479119
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY
D. CHEMSTRIP 5
Lot or serial number
All lots.
Model or catalog number
11893467119
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY
E. CHEMSTRIP 7
Lot or serial number
All lots.
Model or catalog number
11893467119
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY