ADVIA Chemistry System - Urea Nitrogen (UN) Assay (2018-04-05)

Starting date:

April 5, 2018

Posting date:

May 1, 2018

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-66632

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  Reason
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  Affected products

Affected products

ADVIA Chemistry System - Urea Nitrogen (UN) Assay

Reason

Siemens Healthcare Diagnostics has confirmed that the Urea Nitrogen Reagent Kit Lots 408143 and 418290 for use on ADVIA 1800, 2400 and XPT Chemistry Systems demonstrate an increased incidence of calibration failure. Results cannot be generated by the system when calibration fails. If calibration passes, there is a potential for falsely elevated patient and quality control results. Internal testing has also shown that results have the potential to be falsely increased by approximately 10 mg/dl (3.57 mmol/l) across the analytical range. Quality controls may not always detect the elevated results.

Affected products