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Health product recall

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

  1. 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.