Health product recall

Dimension Vista System Cholesterol Assay (2020-05-01)

Starting date:
May 1, 2020
Posting date:
May 15, 2020
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-73111



Last updated: 2020-05-15

Affected Products

Dimension Vista System Cholesterol Assay

Reason

Siemens Healthcare Diagnostics has confirmed the potential for Hydration Quality Control (QC) failures with Dimension Vista Cholesterol (CHOL) Flex reagent cartridge lots 19317AB, 19329AA, 19354AB, 20058AD, 20064AB and 20070AA. This issue is not observed with every Dimension Vista CHOL Flex or with every well within an impacted Dimension Vista CHOL Flex.

Affected products

Dimension Vista System Cholesterol Assay

Lot or serial number
  • 19317AB
  • 19329AA
  • 19354AB
  • 20058AD
  • 20064AB
  • 20070AA
Model or catalog number
  • K1027
Companies
Manufacturer

Siemens Healthcare Diagnostics Inc.

500 GBC Drive, Mailstop 514, P.O. Box 6101

Newark

19714

Delaware

UNITED STATES