ADVIA Chemistry Creatine Kinase (2019-05-15)

Starting date:

May 15, 2019

Posting date:

May 31, 2019

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-70063

Last updated: 2019-05-31

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  Reason
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  Affected products

Affected Products

ADVIA Chemistry Creatine Kinase

Reason

Siemens Healthcare Diagnostics has confirmed increased incidences of system generated (u,u) flags on calibration, quality control and patient results when using the ADVIA Chemistry Creatine Kinase (CK_L) reagent kit lots 465336, 465663, and 468449 on the ADVIA 1800, 2400, and XPT Chemistry Systems.  As per the ADVIA Chemistry Systems operators guide, samples with u or u flags are not to be reported. Siemens has also confirmed for the affected lots that patient results may be falsely decreased or increased across the analytical range even when the u flags are not generated.

Affected products