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Health product recall

DIMENSION VISTA BLOOD UREA NITROGEN (2016-06-03)

Starting date:
June 3, 2016
Posting date:
June 16, 2016
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-58932

Affected products

  1. DIMENSION VISTA BLOOD UREA NITROGEN

Reason

In this follow-up to a February 2016 field correction Siemens is expanding the warning of well-to-well accuracy shifts to additional lots (and all future lots until further notice) of Dimension Vista BUN Flex Reagent Cartridges, resulting in inaccurate patient and/or quality/control results. Not all flexes or wells are impacted. Siemens is providing revised advice to customers to manage bun testing.

Affected products

A. DIMENSION VISTA BLOOD UREA NITROGEN

Lot or serial number
  • 16004AB
  • 16033AC
  • 16034AA
  • 16048AA
  • 16055AA
  • 16055AB
  • 16062AA
  • 16062AB
Model or catalog number
  • K1021
Companies
Manufacturer

Siemens Healthcare Diagnostics Inc.

500 GBC DRIVE, MAILSTOP 514, P.O. BOX 6101

Newark, Delaware

19714-6101

UNITED STATES



DIMENSION VISTA BLOOD UREA NITROGEN (2016-02-24)

2016-02-24 | Health products

Recall


Date modified: