Health product recall

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

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

ADVIA Chemistry Creatine Kinase

Lot or serial number
  • 465336
  • 465663
  • 468449
Model or catalog number

10729780

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