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Quanta Flash DGP IGA calibrators (2015-03-03)
- Starting date:
- March 3, 2015
- Posting date:
- March 27, 2015
- 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-52701
Recalled Products
A. Quanta Flash DGP IGA calibrators
Reason
The kit box and calibrator tubes are correctly labelled with Lot 141010 but the display and reports on the bio-flash system indicate Lot "141009". This was caused by an error in the barcoding of the calibrator tubes, which also assigned target values to the calibrators from lot 141009 rather than from Lot 141010. The target values of the two Lots are comparable. Therefore, results previously reported are not impacted by this recall.
Affected products
A. Quanta Flash DGP IGA calibrators
Lot or serial number
141010
Model or catalog number
701166
Companies
- Manufacturer
-
Inova Diagnostics Inc.
9900 Old Grove Road
San Diego
92131
California
UNITED STATES