DIMENSION VISTA SYSTEM - MAGNESIUM ASSAY (2015-09-24)

Starting date:

September 24, 2015

Posting date:

October 14, 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-55358

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  Reason
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  Affected products

Affected Products

DIMENSION VISTA SYSTEM - MAGNESIUM ASSAY

Reason

Siemens Healthcare Diagnostics has received customer complaints for the Dimension Vista Magnesium (mg) (K3057, 10445158) when using Lot 15063BA. The complaints were related to erroneous low results on a small number of reagent wells. Data collected from the customer complaints shows that there is the potential for under-recovery on certain wells for quality control (QC) and patient sample results. When this issue occurred, the under-recovery ranged from -0.3 mg/dL [0.12 mmol/L] to -1.6 mg/dL [0.66 mmol/L]. The average under-recovery was -1.0 mg/dL [0.41 mmol/L]. This issue is demonstrating a low frequency of occurrence, with an estimated one (1) in every 10,000 tests that may be affected. Siemens internal investigations were unable to reproduce this issue, likely due to the low probability of occurrence. A root cause investigation is ongoing. Repeating the sample on a new well of reagent or a new flex cartridge resolves the issue. This issue is likely to be detected by quality control (QC) or calibrators if they are run on the affected wells of reagent.

Affected products