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Quanta Lite ACA IgG III Kit
- Starting date:
- December 28, 2012
- Posting date:
- December 28, 2012
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices, Labelling and Packaging
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-16833
Recalled Products
- Quanta Lite ACA IgG III Kit
Reason
Some kit labels have the wrong lot number for the HRP Stop Solution (Part # 508509), which is a component of the kit. Some kit labels indicate the correct lot # 003267. Other kit labels show the incorrect lot # of the HRP Stop Solution as 003627.
Affected products
Quanta Lite ACA IgG III Kit
Lot or serial number
003835
Model or catalog number
708625
Companies
- Manufacturer
- Inova Diagnostics Inc.