Health product recall

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