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DIMENSION VISTA BLOOD UREA NITROGEN (2016-02-24)
- Starting date:
- February 24, 2016
- Posting date:
- March 4, 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-57392
Affected Products
DIMENSION VISTA BLOOD UREA NITROGEN
Reason
Siemens healthcare diagnostics has determined that specific lot number/cavity combinations of dimension vista blood urea nitrogen (BUN) Flex Reagent Cartridges may exhibit inaccurate patient and/or quality control results with either falsely depressed or falsely elevated BUN results.
Affected products
DIMENSION VISTA BLOOD UREA NITROGEN
Lot or serial number
- 15215AE
- 15243BB
- 15264BA
- 15299BB
- 15300BA
- 15320BB
- 15341AC
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
Related AWRs
