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Dimension Vista 1500 and 500 Lab Systems (2014-11-06)
- Starting date:
- November 6, 2014
- Posting date:
- November 18, 2014
- 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-42143
Recalled Products
- Dimension Vista 1500 Lab System(Class2)
- Dimension Vista 1500 Lab System(Class3)
- Dimension Vista 500 Lab System
Reason
Siemens has received customer complaints of discrepant flagged and/or unflagged patient and QC results on Dimension Vista Intelligent Lab Systems. Reagent probe performance may decline more quickly than anticipated and have an effect on assays with similar formulations when processed sequentially on the same reagent server. Replacing an associated reagent probe can resolve this issue.
Affected products
A. Dimension Vista 1500 Lab System(Class2)
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
1000033793
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
500 GBC Drive, Mailstop 514, PO Box 6101
Newark
19714-6101
Delaware
UNITED STATES
B. Dimension Vista 1500 Lab System(Class3)
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
1000033793
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
500 GBC Drive, Mailstop 514, PO Box 6101
Newark
19714-6101
Delaware
UNITED STATES
C. Dimension Vista 500 Lab System
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
1000034648
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
500 GBC Drive, Mailstop 514, PO Box 6101
Newark
19714-6101
Delaware
UNITED STATES