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Dimension EXL System-(Troponin) TNI Assay (2013-09-12)
- Starting date:
- September 12, 2013
- Posting date:
- October 28, 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-36443
Recalled Products
Dimension EXL System-(Troponin) TNI Assay
Reason
Some vials of Dimension Loci Cardiac Troponin I calibrator under-recover Troponin I, resulting in over-recovery of QC and patient samples following calibration. Testing on patient samples demonstrated an average upward shift of 24% (Range 1%-33%) when compared to an unaffected lot.
Affected products
Dimension EXL System-(Troponin) TNI Assay
Lot or serial number
- 3DD007
Model or catalog number
- 10464336
- RC621
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
500 GBC Drive, Mailstop 514, PO Box 6101
Newark
19714-6101
Delaware
UNITED STATES