ADVIA Chemistry System-Enzymatic Creatinine_2 (ECRE_2) 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-72141
Last updated: 2020-01-21
Affected Products
ADVIA Chemistry System-Enzymatic Creatinine_2 (ECRE_2) 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
ADVIA Chemistry System-Enzymatic Creatinine_2 (ECRE_2) Assay
Lot or serial number
- 53150
- 53151
- 53152
- 54354
- 54372
- 54373
- 54374
- 54375
- 54786
- 54787
- 54788
- 54789
Model or catalog number
4992596
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave
Tarrytown
10591
New York
UNITED STATES