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Dimension Vista System - Thyroid Stimulating Hormone (TSH) Assay (2015-04-22)
- Starting date:
- April 22, 2015
- Posting date:
- May 21, 2015
- 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-53401
Recalled Products
A. Dimension Vista System - Thyroid Stimulating Hormone (TSH) Assay
Reason
Siemens Healthcare Diagnostics has determined that Dimension Vista loci Thyroid Stimulating Hormone (TSH) lot 14237AA may produce falsely depressed results ranging from -23% to -96% near the end of the well set due to inadequate reagent volume in a flex well. The occurrence of this issue is low. Quality control will detect the issue if it is run near the end of an affected well set.
Affected products
A. Dimension Vista System - Thyroid Stimulating Hormone (TSH) Assay
Lot or serial number
14237AA
Model or catalog number
K6412
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
500 Gbc Drive
Mailstop 514
Delaware
UNITED STATES