Dimension Creatinine Flex Reagent Cartridge (2016-06-09)

Starting date:

June 9, 2016

Posting date:

March 31, 2017

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type III

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-62830

• Reason
• Affected products

Affected Products

1. Dimension Vista System Creatinine (Cre2) Flex Reagent Cartridge
2. Dimension Clinical Chemistry System Creatinine (Cre2) Flex Reagent Cartridge

Reason

Siemens Healthcare Diagnostics has confirmed that Dimension Creatinine (CRE2) Assay and Dimension Vista Creatinine (CRE2) Assay exhibits a negative bias at the low end of the urine analytical measurement range (AMR). The limit of quantitation (LOQ) claim (5 mg/dL [442 umol/L]) for urine samples is not met. Siemens is actively investigating the root cause of the issue and is working to implement a solution. This issue also affects all future lots of CRE2 until a solution is implemented. The serum/plasma CRE2 AMR is not affected by this issue.

Affected products