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Dimension Vista Systems Assays (2017-04-03)
- Starting date:
- April 3, 2017
- Posting date:
- April 21, 2017
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-63078
Affected Products
- Dimension Vista System-Thyroid Stimulating Hormone (Tsh) Assay
- Dimension Vista System-Ferritin (Ferr) Assay (Flex)
- Dimension Exl System-(Troponin) Tni Assay
- Dimension Vista System-Loci Digoxin (Digxn) Assay
- Dimension Vista System-Loci Prolactin (Prl) Assay
- Dimension Vista System Loci Estradiol (E2) Reagent
Reason
Siemens Healthcare Diagnostics has confirmed that the concentrations for biotin listed in the non- interfering substances section of the current dimension and dimension vista instructions for use for Dimension TNI, Dimension Vista DIGXN, E2, FERR, PRL, TSH have incorrect units, and incorrectly state the level at which biotin does not interfere.
Affected products
A. Dimension Vista System-Thyroid Stimulating Hormone (Tsh) Assay
Lot or serial number
All lots
Model or catalog number
- K6412
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
500 GBC DRIVE, MAILSTOP 514, P.O. BOX 6101
Newark
19714-6101
Delaware
UNITED STATES
B. Dimension Vista System-Ferritin (Ferr) Assay (Flex)
Lot or serial number
All lots
Model or catalog number
- K6440
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
500 GBC DRIVE, MAILSTOP 514, P.O. BOX 6101
Newark
19714-6101
Delaware
UNITED STATES
C. Dimension Exl System-(Troponin) Tni Assay
Lot or serial number
All lots
Model or catalog number
- 10464525
- RF621
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
500 GBC DRIVE, MAILSTOP 514, P.O. BOX 6101
Newark
19714-6101
Delaware
UNITED STATES
D. Dimension Vista System-Loci Digoxin (Digxn) Assay
Lot or serial number
All lots
Model or catalog number
- 10488927
- K6435
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
500 GBC DRIVE, MAILSTOP 514, P.O. BOX 6101
Newark
19714-6101
Delaware
UNITED STATES
E. Dimension Vista System-Loci Prolactin (Prl) Assay
Lot or serial number
All lots
Model or catalog number
- 10488398
- K6462
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
500 GBC DRIVE, MAILSTOP 514, P.O. BOX 6101
Newark
19714-6101
Delaware
UNITED STATES
F. Dimension Vista System Loci Estradiol (E2) Reagent
Lot or serial number
All lots
Model or catalog number
- 10489099
- K6463
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
500 GBC DRIVE, MAILSTOP 514, P.O. BOX 6101
Newark
19714-6101
Delaware
UNITED STATES