Dimension Vista System-Enzymatic Creatinine (ECREA) Assay and Dimension EXL System-Enzymatic Creatinine (EZCR) Assay (2019-12-24)
- Starting date:
- December 24, 2019
- Posting date:
- January 20, 2020
- 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-72123
Last updated: 2020-01-21
Affected Products
- Dimension Vista System-Enzymatic Creatinine (ECREA) Assay
- Dimension EXL System-Enzymatic Creatinine (EZCR) Assay
Reason
Siemens Healthcare Diagnostics has become aware of reports of falsely depressed creatinine results for patients on phenindione therapy when using enzymatic methodology. The root cause was confirmed via testing indicating that ADVIA, Dimension and Dimension Vista Enzymatic Creatinine results are potentially interfered by the Phenindione drug and/or its metabolites. Interference has not been
observed with the Jaffe methodology.
Affected products
A. Dimension Vista System-Enzymatic Creatinine (ECREA) Assay
Lot or serial number
- 18298AA
- 18346AA
- 19035AA
- 19101AA
- 19175AA
- 19189AA
- 19192AB
- 19218AB
- 19273AA
Model or catalog number
K1270A
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
500 GBC Drive, Mailstop 514, P.O. Box 6101
Newark
19714
Delaware
UNITED STATES
B. Dimension EXL System-Enzymatic Creatinine (EZCR) Assay
Lot or serial number
- BC9345
- ED0086
- FB0122
- FC9310
- FD9164
- GB9213
- GC0024
- GC0184
- GD0218
- GD9262
Model or catalog number
10471520
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
500 GBC Drive, Mailstop 514, P.O. Box 6101
Newark
19714
Delaware
UNITED STATES