Dimension Vista System, Dimension Xpand System & Dimension Exl System - Total Bilirubin Assay (2020-02-21)
- Starting date:
- February 21, 2020
- Posting date:
- April 24, 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-72859
Last updated: 2020-04-24
Affected Products
- Dimension Vista System - Total Bilirubin Assay
- Dimension Xpand System - Total Bilirubin (TBI) Assay
- Dimension Exl System - Total Bilirubin (TBI) Assay
Reason
Siemens Healthcare Diagnostics has become aware that the United Kingdom Medicines and Healthcare Products Regulatory Agency published an alert to healthcare professionals informing them that laboratory tests for bilirubin should be monitored for patients who take the drug Eltrombopag due to the potential for discordant results. Eltrombopag may be used in the treatment of thrombocytopenia and/or aplastic anemia.
Affected products
A. Dimension Vista System - Total Bilirubin Assay
Lot or serial number
All lots.
Model or catalog number
K1167
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
500 GBC Drive, Mailstop 514, P.O. Box 6101
Newark
19714
Delaware
UNITED STATES
B. Dimension Xpand System - Total Bilirubin (TBI) Assay
Lot or serial number
All lots.
Model or catalog number
10444957
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
500 GBC Drive, Mailstop 514, P.O. Box 6101
Newark
19714
Delaware
UNITED STATES
C. Dimension Exl System - Total Bilirubin (TBI) Assay
Lot or serial number
All lots.
Model or catalog number
10444957
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
500 GBC Drive, Mailstop 514, P.O. Box 6101
Newark
19714
Delaware
UNITED STATES