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