Health product recall

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

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

Atellica CH Creatine Kinase

Lot or serial number
  • 280765
  • 280766
  • 280767
Model or catalog number

11097640

Companies
Manufacturer
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave
Tarrytown
10591
New York
UNITED STATES