CanadaDimension® Creatinine (CRE2) test reagent, model/catalogue number 10872079, with lot numbers GA6307 and BA7005 sold by Siemens Healthcare Diagnostics Inc. is affected. Siemens confirmed a potential for imprecision in quality control and patient sample results when using those lots on the Dimension system. Contact the manufacturer if you require additional information.
What's being recalled
Companies: Siemens Healthcare Diagnostics Inc., 500 Gbc Drive, Newark, Delaware, United States, 19714.
How to identify it
Affected products: Dimension® Creatinine (CRE2); Lot or serial number: GA6307; Model or catalogue number: 10872079
Affected products: Dimension® Creatinine (CRE2); Lot or serial number: BA7005; Model or catalogue number: 10872079
The hazard
Siemens Healthineers has confirmed, through investigation of customer complaints, a potential for imprecision in Dimension® Creatinine (CRE2) quality control (QC) and patient sample results when using lot numbers GA6307 and BA7005 on the dimension system.
What to do
Contact the manufacturer if you require additional information.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)