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Health product recall

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

  1. Dimension Vista System-Thyroid Stimulating Hormone (Tsh) Assay
  2. Dimension Vista System-Ferritin (Ferr) Assay (Flex)
  3. Dimension Exl System-(Troponin) Tni Assay
  4. Dimension Vista System-Loci Digoxin (Digxn) Assay
  5. Dimension Vista System-Loci Prolactin (Prl) Assay
  6. 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