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Dimension Hemoglobin A1C (HB1C) Assay
- Starting date:
- April 10, 2013
- Posting date:
- April 30, 2013
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-28981
Recalled Products
- Dimension Hemoglobin A1C (HB1C) Assay
Reason
Customers have been experiencing a higher frequency of "above assay range" flags on patient samples with the Dimension HB1C method. Upon dilution, the result is usually well within the range of the assay. Some customers understand the issue is hemoglobin being above the assay range of > 25 g/dl and have verified on an independent system that hemoglobin on affected samples are < 25 g/dl. Some customers have experienced a high bias on US cap survey samples (2012 GH2-B) with the HB1C method. Cap samples that failed are in the normal range of the method.
Affected products
A. Dimension Hemoglobin A1C (HB1C) Assay
Lot or serial number
- More than 10 numbers, contact manufacturer
Model or catalog number
- DF105A
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
500 GBC Drive, Mailstop 514, PO Box 6101
Newark
19714-6101
Delaware
UNITED STATES