This page has been archived on the Web
Information identified as archived is provided for reference, research or recordkeeping purposes. It is not subject to the Government of Canada Web Standards and has not been altered or updated since it was archived. Please contact us to request a format other than those available.
Tina-quant Cystatin C (2015-05-14)
- Starting date:
- May 14, 2015
- Posting date:
- June 15, 2015
- 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-53791
Recalled Products
- Tina-quant Cystatin C
- Tina-quant Cystatin C (CYSC)
- CYSC (Tina-quant Cystatin C)
Reason
The specification for "high dose hook effect" for the CYSC2 on all Roche systems has been revised and will be reduced from 20 mg/l to 12 mg/l.
Affected products
A. Tina-quant Cystatin C
Lot or serial number
All lots.
Model or catalog number
- 6600174190
Companies
- Manufacturer
-
Roche Diagnostics Gmbh
Sandhoferstrasse 116
Mannheim
68305
GERMANY
B. Tina-quant Cystatin C (CYSC)
Lot or serial number
All lots.
Model or catalog number
- 6600239190
Companies
- Manufacturer
-
Roche Diagnostics Gmbh
Sandhoferstrasse 116
Mannheim
68305
GERMANY
C. CYSC (Tina-quant Cystatin C)
Lot or serial number
All lots.
Model or catalog number
- 6600263190
Companies
- Manufacturer
-
Roche Diagnostics Gmbh
Sandhoferstrasse 116
Mannheim
68305
GERMANY