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Dimension Hemoglobin A1C Flex Reagent
- Starting date:
- August 17, 2012
- Posting date:
- September 17, 2012
- 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-23877
Recalled Products
A. Dimension Hemoglobin A1C Flex Reagent
Reason
There has been a change to the acceptable range for the 'E' calibration coefficient guideline. The new guideline range is 5 to 8 (conventional units). The guideline range for Lots prior to GA3099 is 6 to 9. The E coefficient range is a criterion used by customers to assess the validity of their calibration. Siemens has also noted that some users are not updating Scaler Values when setting up a calibration (this was implemented beginning with Lot GA3009), resulting in inaccurate values for both patients and controls.
Affected products
A. Dimension Hemoglobin A1C Flex Reagent
Lot or serial number
GA3113, GA3134, GA3141, GA3169, GA3099, GA3162
Model or catalog number
DF105A
Companies
- Manufacturer
- Siemens Healthcare Diagnostics Inc.