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Various Siemens Dimension Systems (2017-10-20)
- Starting date:
- October 20, 2017
- Posting date:
- October 30, 2017
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- Hospitals, General Public, Healthcare Professionals
- Identification number:
- RA-65000
Affected products
- DIMENSTION VISTA SYSTEM-THYROID STIMULATING HORMONE (TSH) ASSAY
- DIMENSION VISTA SYSTEM-MASS CREATINE KINASE MB ISOENZYME (MMB)
- DIMENSION VISTA SYSTEM-CARDIAC TROPONIN I (CTNI)
- DIMENSION EXL SYSTEM-FREE THYROXINE (FT4L) ASSAY
- DIMENSION EXL SYSTEM-THYROID STIMULATING HORMONE (TSHL) ASSAY
- DIMENSION CHEMISTRY SYSTEM-SIROLIMUS (SIRO) ASSAY
- DIMENSION XPND SYSTEM-SIROLIMUS (SIRO) ASSAY
- DIMENSION EXL SYSTEM-SIROLIMUS (SIRO) ASSAY
Reason
The biotin concentration in the non-interfering table for dimension FT4L and TSHL and Dimension Vista TSH is incorrect and the biotin concentration is being revised. In addition, Dimension Vista CTNI and MMB and Dimension SIRO do not indicate biotin interference in the non-interfering table of the IFU. The IFU will be updated with the established claim for biotin.
Affected products
A. DIMENSTION 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-MASS CREATINE KINASE MB ISOENZYME (MMB)
Lot or serial number
All lots
Model or catalog number
K6420
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
500 GBC DRIVE, MAILSTOP 514, P.O. BOX 6101
Newark
19714-6101
Delaware
UNITED STATES
C. DIMENSION VISTA SYSTEM-CARDIAC TROPONIN I (CTNI)
Lot or serial number
All lots
Model or catalog number
K6421
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
500 GBC DRIVE, MAILSTOP 514, P.O. BOX 6101
Newark
19714-6101
Delaware
UNITED STATES
D. DIMENSION EXL SYSTEM-FREE THYROXINE (FT4L) ASSAY
Lot or serial number
All lots
Model or catalog number
RF610
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
500 GBC DRIVE, MAILSTOP 514, P.O. BOX 6101
Newark
19714-6101
Delaware
UNITED STATES
E. DIMENSION EXL SYSTEM-THYROID STIMULATING HORMONE (TSHL) ASSAY
Lot or serial number
All lots
Model or catalog number
RF612
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
500 GBC DRIVE, MAILSTOP 514, P.O. BOX 6101
Newark
19714-6101
Delaware
UNITED STATES
F. DIMENSION CHEMISTRY SYSTEM-SIROLIMUS (SIRO) ASSAY
Lot or serial number
All lots
Model or catalog number
DF306
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
500 GBC DRIVE, MAILSTOP 514, P.O. BOX 6101
Newark
19714-6101
Delaware
UNITED STATES
G. DIMENSION XPND SYSTEM-SIROLIMUS (SIRO) ASSAY
Lot or serial number
All lots
Model or catalog number
DF306
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
500 GBC DRIVE, MAILSTOP 514, P.O. BOX 6101
Newark
19714-6101
Delaware
UNITED STATES
H. DIMENSION EXL SYSTEM-SIROLIMUS (SIRO) ASSAY
Lot or serial number
All lots
Model or catalog number
DF306
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
500 GBC DRIVE, MAILSTOP 514, P.O. BOX 6101
Newark
19714-6101
Delaware
UNITED STATES