Atellica CH 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-70065

Last updated: 2019-05-31

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  Reason
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  Affected products

Affected Products

Atellica CH Creatine Kinase

Reason

Siemens Healthcare Diagnostics has confirmed increased incidences of calibration failures when using the Creatine Kinase kits lot numbers 280765, 280766, 280767 on the Atellica CH Analyzer. Results cannot be generated by the system when the calibration fails. Siemens has also confirmed that for these affected lots, when calibration passes, patient results have the potential to be falsely decreased or increased across the analytical range. Quality control may or may not detect the issue.

Affected products