ADVIA CHEMISTRY SYSTEMS REAGENTS (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 II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-55360

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  Reason
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  Affected products

Products Affected

1. ADVIA 1200 CHEMISTRY SYSTEM-HEMOGLOBIN A1C_3 REAGENTS
2. ADVIA CHEMISTRY SYSTEMS-HEMOGLOBIN A1C_3 REAGENTS

Reason

Siemens Healthcare Diagnostics has confirmed the Hemoglobin A1c_3 and A1c_3M reagent affected kit lots used on the ADVIA 1200, 1650, 1800, 2400, and XPT Chemistry Systems may demonstrate an increased occurrence of high %HbA1c (glycosylated hemoglobin) bias. Siemens internal investigation demonstrates reagent lots 230 and 231 may exhibit a positive bias averaging 0.6% HbA1c units, ranging from -0.1% to 1.1% HbA1c units. The bias was observed when comparing %HbA1c means to National Glycohemoglobin Standardization Program (NGSP) pooled patient target-value assigned samples ranging from approximately 5.5% to 8.0% HbA1c. The maximum bias was observed at higher %HbA1c concentrations. Quality control samples may exhibit a similar bias.

Affected products