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Dimension Vista Intelligent Lab Systems (2017-03-06)
- Starting date:
- March 6, 2017
- Posting date:
- April 4, 2017
- 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-62882
Affected Products
A. Dimension Vista 1500 Intelligent Lab System
B. Dimension Vista 500 Intelligent Lab System
Reason
In isolated cases when ECREA is processed immediately after the weekly automated acid clean routine during probe test, there is the remote potential for an elevation of greater than 15 percent in the ECREA result. Investigation has determined that the processing of ECREA quality control after the probe test will identify a potential elevated ECREA result.
Affected products
A. Dimension Vista 1500 Intelligent Lab System
Lot or serial number
More than 10, contact manufacturer
Model or catalog number
1000033793
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
500 GBC DRIVE, MAILSTOP 514, P.O. BOX 6101
Newark
19714-6101
Delaware
UNITED STATES
B. Dimension Vista 500 Intelligent Lab System
Lot or serial number
More than 10, contact manufacturer
Model or catalog number
1000034648
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
500 GBC DRIVE, MAILSTOP 514, P.O. BOX 6101
Newark
19714-6101
Delaware
UNITED STATES