DIMENSION CREATININE SYSTEMS (2015-07-21)

Starting date:

July 21, 2015

Posting date:

August 10, 2015

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-54560

• Reason
• Affected products

Affected Products

• A. DIMENSION VISTA SYSTEM CREATININE (CREA)
• B. DIMENSION SYSTEM CREATININE (CREA)
• C. DIMENSION XPAND SYSTEM CREATININE (CREA)
• D. DIMENSION EXL SYSTEM CREATININE (CREA)

Reason

Siemens has confirmed hemoglobin (HB) interference (greater than 10 percent) for dimension Crea above 200 mg/dl HB at a creatinine concentration of 1.5 mg/dl and for dimension vista Crea above 200 mg/dl HB at a creatinine concentration of 1.5 mg/dl. Current claims for HB interference are less than 10 percent at these Crea and HB concentrations.

Affected products