Advia 1200 Chemistry System - A1C_3 Calibrator and Advia Chemistry System - A1C_3 Calibrator (2014-08-07)

Starting date:

August 7, 2014

Posting date:

August 22, 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-41117

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  Reason
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  Affected products

Recalled Products   

1. Advia 1200 Chemistry System – A1C_3 Calibrator
2. Advia Chemistry System – A1C_3 Calibrator

Reason

Multiple customer complaints were received reporting HBA1C bias on patient samples and for cap survey failures when using A1C_3 calibrator lots 3HD044, 3LD068. Siemens has confirmed a -9% to -11% bias on these calibrator lots. The quality control values although high biased, recover within assigned ranges - therefore may not detect the issue. An internal complaint was also generated for NGSP certification failure due to a low bias.

Affected products