Dimension Vista System - Hemoglobin A1c (HbA1c), Dimension EXL system - Hemoglobin A1c (Hb1c),Dimension Xpand system - Hemoglobin A1c (Hb1c) and Dimension Cinical Chemistry System - Hemoglobin a (2014-09-24)

Starting date:

September 24, 2014

Posting date:

October 10, 2014

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-41745

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  Reason
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  Affected products

Recalled Products

A) Dimension Vista System - Hemoglobin A1c (HbA1c)

B) Dimension EXL system - Hemoglobin A1c (Hb1c)

C) Dimension Xpand system - Hemoglobin A1c (Hb1c)

D) Dimension Cinical Chemistry System - Hemoglobin a

Reason

Siemens Healthcare Diagnostics is conducting a field recall for Dimension Vista HbA1c and Dimension Hb1C flex reagent lots listed in section 64(a) of this report. Siemens has confirmed that these reagent cartridge lots exhibit positive bias averaging 0.4% [4.4 mmol/mol] Hemoglobin A1c units and occasionally up to 1.0% [11 mmol/mol] HbA1c units for patient samples when compared to the national glycol-hemoglobin standardization program (NGSP). QC samples may exhibit a similar bias.  As the customer base may differ based on the platform being utilized, Siemens is issuing two Urgent Field Safety Notices (UFSN): one UFSN is being issued for the affected lots of Dimension Vista Hemoglobin A1c (HbA1c). The second UFSN is being issued for the affected lots of Dimension Hemoglobin A1c (HbA1c). Customers will receive the letters pertinent to them. Both letters contain the same content, differing only in the specified product code and lot numbers.

Affected products