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Dimension Chemistry Systems
- Starting date:
- May 27, 2013
- Posting date:
- July 23, 2013
- 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-34717
Recalled products
- Dimension Chemistry System-Mass CKMB
- Dimension Xpand System-LMMB Mass Creatine Kinase MB Isoenzyme Flex Assay
- Dimension EXL System-Mass Creatine Kinase MB Isoenzyme (MMB) Assay
Reason
Siemens has received customer complaints that the lyophilized cake is not fully dissolved after the stated time in the mmb calibrator instructions for use (IFU). The frequency of this occurrence is low but if it occurs, gel-like clumps may be observed.
Affected products
A. Dimension Chemistry System-Mass CKMB
Lot or serial number
- 2GD053
Model or catalog number
- RC420
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
500 GBC Drive, Mailstop 514, PO Box 6101
Newark
19714-6101
Delaware
UNITED STATES
B. Dimension Xpand System-LMMB Mass Creatine Kinase MB Isoenzyme Flex Assay
Lot or serial number
- 2KD024
Model or catalog number
- RC420
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
500 GBC Drive, Mailstop 514, PO Box 6101
Newark
19714-6101
Delaware
UNITED STATES
C. Dimension EXL System-Mass Creatine Kinase MB Isoenzyme (MMB) Assay
Lot or serial number
- 3AD051
Model or catalog number
- RC420
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
500 GBC Drive, Mailstop 514, PO Box 6101
Newark
19714-6101
Delaware
UNITED STATES